[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-large-b-cell-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,135,0,25,[9,43,63,94,117,166,192,225,250,280,306,327,357,385,418,455,485,509,529,553,582,609,631,649,669],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100571215","phase-3-a-study-to-evaluate-zilovertamab-vedotin-mk-2140-combination-with-rituximab-plus-cyclophosphamide-doxorubicin-and-prednisone-r-chp-versus-rituximab-plus-cyclophosphamide-doxorubicin-vincristine-and-prednisone-r-chop-in-participants-with-previously-untreated-dlbcl-mk-2140-010-100571215",false,"NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant","ALL","18 Years",{"count":20,"type":21},1046,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[27],"Diffuse Large B-Cell Lymphoma",[29],"Lymphoma, Large B-Cell, Diffuse","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2025-01-27",{"date":38,"type":21},"2032-03-29",{"name":40,"class":41},"Merck Sharp & Dohme LLC","INDUSTRY",268,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":5},"100449940","phase-2-a-study-of-zilovertamab-vedotin-mk-2140-in-combination-with-standard-of-care-in-participants-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-rrdlbcl-mk-2140-003-100449940","NCT05139017","A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)","A Phase 2\u002F3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)","Inclusion Criteria:\n\n* Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).\n* Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.\n* Has adequate organ function.\n* Is able to provide new or archival tumor tissue sample not previously irradiated.\n\nZilovertamab vedotin plus R-GemOx, or R-GemOx study arms:\n\n* Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.\n* Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy.\n\nNot applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms:\n\n* Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 2 lines of prior therapy.\n* Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy.\n\nExclusion Criteria:\n\n* Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL\n* Has received solid organ transplant at any time.\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).\n* Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication.\n* Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.\n* Has clinically significant pericardial or pleural effusion.\n* Has ongoing Grade \\>1 peripheral neuropathy.\n* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n* Has a demyelinating form of Charcot-Marie-Tooth disease.\n* Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction.\n* Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.\n* Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has ongoing corticosteroid therapy.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n* Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known active Hepatitis C virus infection.\n* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.",{"count":51,"type":21},290,[53,24],"PHASE2","The purpose of this Phase 2\u002F3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.\n\nWith protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \\[BR\\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.",[56,27],"DLBCL",{"date":33,"type":34},{"date":59,"type":34},"2022-01-14",{"date":61,"type":21},"2027-09-24",{"name":40,"class":41},{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778","NCT05006716","A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":72,"type":21},645,[74,53],"PHASE1","Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[77,78,79,80,81,82,83,84,85],"B-cell Malignancy","Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma",{"date":33,"type":34},{"date":88,"type":34},"2021-09-13",{"date":90,"type":21},"2029-11",{"name":92,"class":41},"BeOne Medicines",115,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100533531","phase-1-pilot-study-of-anti-cd19-chimeric-antigen-receptor-t-cells-car-t-cells-for-the-treatment-of-relapsedrefractory-cd19-malignancies-100533531","NCT06227026","Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed\u002FRefractory CD19+ Malignancies","PRODIGY","Inclusion Criteria:\n\n* Subjects aged ≥ 18 years.\n* Histologically confirmed relapsed or refractory CD-19+ malignancy, including: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)\u002FRichter's syndrome. CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis.\n* Subjects who have relapsed or refractory disease after failing at least 2 or more prior lines of therapy.\n* ECOG Performance Status ≤ 2.\n* Life expectancy \\> 12 weeks.\n* Willing to consent to 15 years of follow-up as part of IRB 110692: Long-Term Evaluation of the Biology and Outcomes of Hematopoietic Stem Cell Transplantation\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 500\u002Fmm3\n    * Platelet count ≥ 10,000\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002FdL\n  * Hepatic:\n\n    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN).\n    * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n  * Renal:\n\n    * Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \\>30 ml\u002Fmin\u002F1.73m2\n* For subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Subjects \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Subjects ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago\n* Subjects of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.\n* Recovery to baseline or ≤ Grade 2 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered stable by the treating investigator.\n* Adequate venous access.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Step 2 Eligibility Confirmation\n\n  * The following criteria must be confirmed within 7 days prior to lymphodepletion. If all criteria are not met, lymphodepletion should be delayed.\n\n    * Confirmation of successful CAR-T manufacturing.\n    * No evidence or suspicion of an infection.\n    * Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \\>30 ml\u002Fmin\u002F1.73m2\n    * No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risk from lymphodepleting chemotherapy or exclude them from treatment with study CAR-T therapy.\n* Step 3 Eligibility Confirmation\n\n  * The following criteria must be confirmed prior to CAR-T therapy. If all criteria are not met, CAR-T therapy should be delayed.\n\n    * No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risks from treatment with CAR-T therapy.\n    * Confirmation that washout periods outlined in section 6.6 and Appendix 10 have been followed.\n\nExclusion Criteria:\n\n* Autologous or allogeneic stem cell transplant or CAR-T therapy within 6 weeks of planned CAR-T cell infusion.\n* Subjects with active infection that requires systemic treatment\n* History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of child bearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.\n* Receiving other investigational agents.\n* Confirmation that washout periods listed in Appendix 10 have been followed.\n* Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.\n* The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and\u002For will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6). Patients with transformed disease are allowed.\n* Known brain metastases or cranial epidural disease. Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and\u002For surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 500 ms.\n    * Known congenital long QT.\n    * Left ventricular ejection fraction \\\u003C 55%.\n    * Uncontrolled hypertension defined as ≥ 140\u002F90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or seropositive HIV. Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).\n* Subjects taking prohibited medications as described in Section 6.6 and Appendix 10. Unless otherwise stated, a washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.\n* Subjects with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.",{"count":102,"type":21},10,[74],"This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells.\n\nThis study will utilize a staggered enrollment design with a safety observation period.",[106,85],"Acute Lymphoblastic Leukemia","2026-08-19",{"date":33,"type":34},{"date":110,"type":34},"2024-02-20",{"date":112,"type":21},"2028-05",{"name":114,"class":115},"University of Utah","OTHER",1,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":136,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100370548","phase-1-a-study-of-tulmimetostat-dzr123-cpi-0209-in-patients-with-advanced-solid-tumors-and-lymphomas-100370548","NCT04104776","A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","A Phase 1\u002F2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","Key Inclusion Criteria:\n\nAll Patients:\n\n* Adults aged ≥18 years with life expectancy ≥12 weeks\n* ECOG performance status 0-1\n* Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)\n* Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds\n* Willingness to provide tumor tissue and blood samples for biomarker analyses\n* Agreement to protocol-specified contraception requirements\n* Signed informed consent prior to study procedures\n\nDisease-Specific Inclusion Criteria:\n\nPhase 1 (Dose Escalation):\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma\n* Disease refractory to standard therapy or with no available effective standard treatment\n* For prostate cancer: castrate testosterone levels maintained throughout the study\n\nPhase 2 (Disease-Specific Cohorts):\n\n* M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)\n* M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)\n* M3: ARID1A mutant recurrent\u002Fmetastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy\n* M4: Relapsed\u002Frefractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease\n* M5: Relapsed\u002Frefractory pleural or peritoneal mesothelioma with documented BAP1 loss\n* M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy\n* M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)\n* M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure\n\nKey Exclusion Criteria:\n\nAll Patients:\n\nMedical Conditions:\n\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Active or untreated symptomatic CNS metastases (with limited exceptions)\n* Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled infections or significant gastrointestinal disorders affecting absorption\n* Active HIV or hepatitis B\u002FC infection\n* Concurrent malignancy requiring active treatment (with protocol-defined exceptions)\n* Pregnancy, breastfeeding, or inability to comply with protocol requirements\n\nPrior or Concomitant Therapy:\n\n* Recent anticancer therapy within protocol-defined washout periods\n* Prior EZH2 inhibitor treatment\n* Recent radiation or liver-directed therapies outside allowed windows\n* Use of strong CYP3A4\u002F5 inhibitors or inducers\n\nAdditional Cohort-Specific Exclusions:\n\n* M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies\n* M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease",{"count":125,"type":21},300,[74,53],"The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.",[129,85,130,131,132,133,134,135],"Advanced Solid Tumor","Lymphoma, T-Cell","Mesothelioma, Malignant","Prostatic Neoplasms, Castration-Resistant","Endometrial Cancer","Ovarian Clear Cell Carcinoma","Metastatic Castration-resistant Prostate Cancer",[137,138,29,139,140,141,142,143,144,145,146,147,148,149,150,151,152,133,134,153,154,155,156],"Tulmimetostat","DZR123","Lymphoma, B-cell","Lymphoma, T-cell","Lymphoma, Non-Hodgkin","Lymphoma","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Topoisomerase Inhibitors","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents","Food effect","Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)","ARID1A wildtype (ARID1A WT) endometrial carcinoma","Metastatic castration-resistant prostate cancer (mCRPC)","2026-08-18",{"date":107,"type":34},{"date":160,"type":34},"2019-09-18",{"date":162,"type":21},"2030-02-27",{"name":164,"class":41},"Novartis Pharmaceuticals",80,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":116},"100302934","phase-1-venetoclax-ibrutinib-prednisone-obinutuzumab-and-revlimid-vipor-in-relapsedrefractory-b-cell-lymphoma-100302934","NCT03223610","Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","Phase 1b\u002F2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","* INCLUSION CRITERIA:\n* Patients must have histologically or cytologically confirmed B-cell lymphoma confirmed by the Laboratory of Pathology, NCI, as follows:\n\nPhase1b\n\n* Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as High-grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n\n  -Indolent B-cell lymphoma:\n* CLL\u002FSLL is excluded given alternative dosing of FDA-approved venetoclax for relapsed 17p CLL and increased risk of TLS with CLL\u002FSLL compared to other non-Hodgkin lymphomas.\n\n  * NOTE: Patients with known active CNS lymphoma are not eligible.\n\nPhase 2\n\n* Relapsed and\u002For refractory DLBCL and subtypes, including transformed lymphoma as well as High grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n* Relapsed and\u002For refractory Follicular lymphoma (FL)\n* Relapsed and\u002For refractory and untreated Mantle cell lymphoma (MCL)\n* Relapsed and\u002For refractory disease on at least 1 prior treatment regimen, as follows:\n\n  * Aggressive B-cell lymphoma:relapsed after and\u002For refractory to at least 1 prior anthracycline-containing regimen\n  * Indolent B-cell lymphoma: relapsed after and\u002For refractory to at least 1 prior anti-CD20 antibody-containing regimen.\n* NOTE: Patients with untreated and relapsed and\u002For refractory MCL will be included in the phase 2 MCL expansion.\n* Patients must have evaluable disease by clinical exam (i.e. palpable lymphadenopathy, measurable skin lesions, etc.), laboratory assessment (i.e. lymphoma involvement of bone marrow or peripheral blood by morphology, cytology or flow cytometry), and\u002For imaging (measurable lymph nodes or masses on CT or MRI and\u002For evaluable FDG-avid lesions on PET).\n* NOTE: Lesions that have been irradiated cannot be included in the tumor assessment unless unequivocal tumor progression has been documented in these lesions after radiation therapy.\n* Age greater than or equal to 18 years\n* NOTE: Because no dosing or adverse event data are currently available on the use of venetoclax in combination with ibrutinib, obinutuzumab, prednisone and Revlimid(R) in patients \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status less than or equal to 2\n* Adequate organ and marrow function as defined below unless dysfunction is secondary to lymphoma:\n\n  * absolute neutrophil count\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 1,000\u002FmcL\n  * hemoglobin\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 8 g\u002FdL\n  * platelets greater than or equal to 75,000\u002FmcL\n  * INR: less than or equal to 1.5 X institutional upper limit of normal (ULN) for patients not receiving therapeutic anticoagulation\n  * PTT\u002FaPTT: less than or equal to 1.5 X institutional ULN normal except if, in the opinion of the investigator, the aPTT is elevated because of a positive Lupus Anticoagulant\n  * Total Bilirubin: less than or equal to 1.5 X institutional ULN (or less than or equal to 3 X institutional ULN for patients with documented Gilberts syndrome)\n  * AST(SGOT)\u002FALT(SGPT): less than or equal to 2.5 X institutional ULN\n  * Serum Creatinine: less than or equal to 2.0mg\u002FdL OR\n  * Creatinine Clearance: greater than or equal to 60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above 2 mg\u002FdL\n\nCr Cl will be calculated with the use of the 24-hour creatinine clearance or modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass \\[IBM\\] instead of mass):\n\n(140 - Age) x IBM (kg) x \\[0.85 if female\\]\u002F 72 x serum creatinine (mg\u002FdL)\n\n\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n* Immune-modulating drugs (IMiDs) including Revlimid(R) are known to be teratogenic and potential embryo-fetal harm can be seen with use of venetoclax and ibrutinib. The effects of obinutuzumab on the developing human fetus is unknown. For these reasons, women of child-bearing potential and men must agree to use adequate contraception as described below.\n* For women of childbearing potential:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year as outlined below.\n  * Female subjects of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days and again within 24 hours prior to prescribing Revlimid(R) for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS(TM) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking Revlimid(R). FCBP must also agree to ongoing pregnancy testing.\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (greater than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n  * Examples of contraceptive methods with a failure rate of less than 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* For men:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of less than 1% per year as noted below. Men must refrain from donating sperm during this same period.\n  * With pregnant female partners, men must remain abstinent or use a condom as noted below to avoid exposing the embryo.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* Contraception Requirements:\n\nPre-Treatment\u002FDuring Treatment:\n\n--All Drugs- Women- begins 28 days prior to treatment; Men- Begins on day 1\n\nPost-Treatment:\n\n* Venetoclax- Women- 90 days; Men 90 days\n* Ibrutinib- Women- 3 months; Men- 3 months\n* Obinutuzumab- Women- 18 months; Men- 6 months\n* Revlimid- Women-28 days; Men- 28 days\n\n  * All study participants must be registered into the mandatory Revlimid REMS(TM) program and be willing and able to comply with the requirements of Revlimid REMS(TM). NOTE: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS(TM) program\n  * Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nThe following restrictions apply to current or prior anti-cancer treatment, prior to the first dose of study drug:\n\n* Patients who are actively receiving any other investigational agents.\n* Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug\n* Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug\n* Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment\n* Prior allogeneic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug\n* Not recovered (i.e., less than or equal to Grade 1 or baseline) from adverse events due to previously administered anti-cancer treatment, surgery, or procedure. NOTE: Exceptions to this include events not considered to place the subject at unacceptable risk of participation in the opinion of the PI (e.g., alopecia).\n\n  * Patients requiring the use of warfarin are excluded because of potential drug-drug interactions that may potentially increase the exposure of warfarin.\n  * Patients requiring the following agents within 7 days prior to the first dose of venetoclax are excluded:\n* Strong CYP3A inhibitors\n* Strong CYP3A inducers\n\nNOTE: Moderate CYP3A inhibitors and inducers should be used with caution and an alternative medication used, whenever possible.\n\nUncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n* Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\n* Uncontrolled and\u002For symptomatic thyroid disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to Cycle 1, Day 1;\n* Known infection with human T-cell leukemia virus 1 (HTLV-1)\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis; as well as active infection with HBV or HCV:\n\n  --Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\n* Patients with occult or prior HBV infection (defined as positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) with negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo HBV DNA testing during treatment and in surveillance for at least 12 months after completion of study therapy.\n* Malabsorption syndrome or other condition that precludes enteral route of administration\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women, or women who intend to become pregnant during the study, are excluded from this study because Revlimid(R) has known teratogenic effects and venetoclax, ibrutinib and obinutuzumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on study.\n* HIV-positive patients are ineligible because of the potential for pharmacokinetic interactions with venetoclax, ibrutinib and Revlimid(R) and combination antiretroviral therapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Evidence of active tumor lysis syndrome based on laboratory assessment\n* History of recent major surgery within 6 weeks prior to the start of Cycle 1, Day 1 other than for diagnosis\n* History of other active malignancy that could affect compliance with the protocol or interpretation of results\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible.\n  * Patients with a malignancy that has been treated with curative intent will also be eligible. Individuals in documented remission without treatment for greater than or equal to 2 years prior to enrollment may be included at the discretion of the investigator.\n* Known allergy to both xanthine oxidase inhibitors and rasburicase; or, known hypersensitivity to any of the study drugs","120 Years",{"count":175,"type":21},155,[74,53],"Background:\n\nB-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR).\n\nObjective:\n\nTo study the safety of ViPOR for people with B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after treatment\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood, urine, and heart tests\n* Tissue sample from previous procedure\n* Imaging scans\n* Registration for counseling on the risks of lenalidomide. They must get counseling at least every 28 days.\n\nParticipants will have a bone marrow aspiration before treatment.\n\nParticipants may have tumor samples taken.\n\nParticipants will get ViPOR in 21-day cycles. For up to 6 cycles:\n\n* Participants will get one drug by IV on days 1 and 2.\n* Participants will take the other four drugs by mouth on most days. After their first dose of venetoclax, they will stay in the clinic for at least 8 hours and return the next day for monitoring. They may be admitted for more drugs or monitoring.\n\nParticipants will keep a drug diary.\n\nParticipants will have a physical exam and blood and urine tests at least once per cycle. They will have scans 4 times over 6 cycles.\n\nParticipants will have a visit about 1 month after their last dose of study drug. They will then have visits every few months for 3 years, and once a year for years 4 and 5. Visits include a physical exam, blood tests, and scans.",[142,80,27,179],"Burkitt Lymphoma",[181,182],"Monoclonal Antibody","Dose-Finding","2026-08-15",{"date":157,"type":34},{"date":186,"type":34},"2018-02-09",{"date":188,"type":21},"2027-12-01",{"name":190,"class":191},"National Cancer Institute (NCI)","NIH",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100651765","r-ma-pd-1-versus-r-ma-in-treatment-naive-primary-cns-lymphoma-100651765","NCT07764601","R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma","A Prospective, Open-label, Randomized Controlled Study Comparing Rituximab, Methotrexate, Cytarabine, and Penpulimab (R-MA-PD-1) Versus Rituximab, Methotrexate, and Cytarabine (R-MA) in Treatment-naive Patients With Primary Central Nervous System Lymphoma","RM-MA-PD1","Inclusion Criteria:\n\n1. Fully understands the study and voluntarily signs informed consent.\n2. Age 18 to 80 years.\n3. Treatment-naive, pathologically (immunophenotypically) confirmed PCNSL (per 2016 WHO classification).\n4. Diffuse large B-cell lymphoma originating in the CNS without other organ involvement, confirmed by PET-CT or contrast-enhanced CT.\n5. Expected survival more than 3 months.\n6. Laboratory: creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault); INR ≤1.5 x ULN or aPTT ≤1.5 x ULN (INR 2-3 allowed if on warfarin); LVEF ≥50%.\n7. GFR ≥60 mL\u002Fmin.\n8. Participants of childbearing potential must agree to use effective contraception during the study and for 30 days after the last dose.\n\nExclusion Criteria:\n\n1. Contraindication to any study drug.\n2. Clinically significant liver disease, including viral or other hepatitis or cirrhosis (active HBV or active hepatitis C as defined).\n3. HIV infection.\n4. History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of penpulimab.\n5. Prior anti-PD-1\u002FPD-L1\u002FPD-L2, anti-CTLA-4 antibody, CAR-T, or any other agent targeting T-cell co-stimulation or checkpoint pathways.\n6. Congestive heart failure (NYHA \\>2); acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months.\n7. Congenital long QT syndrome or QTcF \\>480 ms.\n8. Other malignancy within the past 5 years (except adequately treated in situ cervical carcinoma, basal cell skin carcinoma, in situ breast carcinoma, or a second primary cancer cured and recurrence-free for 5 years).\n9. Pregnant or lactating women, or intending to become pregnant during the study.\n10. History of clinically significant neurological or psychiatric disorder, or substance\u002Fdrug abuse.\n11. Clinically significant active infection.","80 Years",{"count":202,"type":21},58,[204],"NA","This is a prospective, open-label, multicenter, randomized controlled study in treatment-naive patients with primary central nervous system lymphoma (PCNSL, DLBCL type). Eligible participants are randomized 1:1 to the experimental arm (R-MA-PD-1: rituximab, methotrexate, cytarabine plus penpulimab) or the control arm (R-MA: rituximab, methotrexate, cytarabine). Induction is administered every 21 days for 6 cycles, followed by risk- and response-adapted consolidation (ASCT or whole-brain radiotherapy) and penpulimab maintenance. The primary objective is to compare the 2-year progression-free survival rate between the two arms.",[207,27],"Primary Central Nervous System Lymphoma",[209,210,211,212,213],"PCNSL","Penpulimab","PD-1 inhibitor","High-dose methotrexate","Rituximab","NOT_YET_RECRUITING","2026-08-12",{"date":217,"type":34},"2026-08-14",{"date":219,"type":21},"2026-08",{"date":221,"type":21},"2029-08",{"name":223,"class":115},"WEI XU",5,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":116},"100362726","phase-2-acalabrutinib-with-da-epoch-r-or-r-chop-for-people-with-untreated-diffuse-large-b-cell-lymphoma-100362726","NCT04002947","Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma","A Phase 2 Study of Acalabrutinib With DA-EPOCH-R or R-CHOP for Patients With Untreated Diffuse Large B-cell Lymphoma","-INCLUSION CRITERIA:\n\n1. Patients must have a confirmed histologic diagnosis of an aggressive B-cell lymphoma with morphologic appearance of DLBCL or high-grade B-cell lymphoma (HGBL) confirmed by the Laboratory of Pathology, NCI, with no prior treatment for DLBCL or HGBL. The following subtypes are included:\n\n   * DLBCL, NOS, Activated B-cell type (ABC)\n   * DLBCL, NOS, Germinal center B-cell type (GCB)\n   * T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n   * Primary cutaneous DLBCL, leg-type\n   * EBV+ DLBCL, NOS\n   * DLBCL associated with chronic inflammation\n   * ALK+ large B-cell lymphoma\n   * High-grade B-cell lymphoma, NOS\n   * High-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements\n\n   NOTE: Presence of concomitant indolent lymphomas such as follicular lymphoma, marginal zone lymphomas, monoclonal B-cell lymphocytosis or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma that are best categorized as composite or transformed lymphomas are allowed.\n2. A formalin-fixed tissue block or 15 slide of tumor sample (archival or fresh) must be available for performance of correlative studies.\n\n   NOTE: Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator. Patients must be willing to have a tumor biopsy if adequate archival tissue is not available (i.e., post-enrollment and prior to treatment).\n3. Measurable lymph nodes or masses of at least 1.5 centimeters (cm) on baseline CT or MRI\n4. Stage II, III, or IV disease as classified by the Ann Arbor Classification\n5. Age greater than or equal to 18 years\n6. ECOG performance status less than or equal to 2.\n7. Adequate organ and marrow function as defined below unless dysfunction is felt to be secondary to lymphoma involvement as determined by the treating investigator:\n\n   * absolute neutrophil count\\* \\>=1,000\u002FmcL\n   * hemoglobin\\* \\>= 8 g\u002FdL (transfusions permitted to meet criteria)\n   * Platelets \\>= 75,000\u002FmcL (transfusions not permitted)\n   * total bilirubin \\\u003C= 1.5 X institutional ULN (or \\\u003C= 3 X institutional ULN for patients with documented Gilberts syndrome or cholestatic obstruction or involvement by lymphoma)\n   * AST(SGOT)\u002FALT(SGPT) \\\u003C= 3 X institutional ULN (\\\u003C= 5 x ULN for patients with cholestatic obstruction or involvement by lymphoma\n   * Serum creatinine \\\u003C= 2.0 mg\u002FdL\n\n   OR\n\n   -Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above 2 mg\u002FdL\n\n   \\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n   NOTE: In patients without bone marrow involvement, transfusions of RBCs are permitted to achieve the criterion hemoglobin of 8g\u002Fdl, but transfusions of platelets are not permitted to achieve the criterion platelet count of \\>75,000\u002FmcL. In patients with bone marrow involvement, all transfusions are permissible at the discretion of the investigator.\n8. Effects of acalabrutinib on the developing human fetus are unknown. For these reasons the following measures apply:\n\n   * Individuals of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment.\n   * Individuals of childbearing potential who are sexually active must agree to highly effective contraception prior to study entry, for the duration of study participation, and for at least 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later. Individuals who can father children must use highly effective contraception prior to study entry, for the duration of study participation, and for 12 months after the last dose of combined chemotherapy; there is no contraception timing requirement post-last dose of acalabrutinib alone if an individual who can father children does not initiate chemotherapy on study after the acalabrutinib window.\n   * Participants must not be planning to conceive or father children within the projected duration of the trial, starting with the pre-screening\u002Fscreening visit through 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later.\n\n   NOTE: An individual is considered of childbearing potential, (i.e., fertile), following menarche and until becoming post-menopausal unless permanently sterile or have a congenital or acquired condition that prevents childbearing. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy at least 6 weeks before screening. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. In individuals of childbearing potential \\\u003C45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in individuals of childbearing potential not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient The investigator or a designated associate is requested to advise the subject how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence.\n\n   Individuals who can father children are considered to be of non-reproductive potential if they are permanently sterile due to bilateral orchiectomy.\n\n   Highly effective methods of contraception (to be used during heterosexual activity) are defined as methods that can achieve a failure rate of \\\u003C1% per year when used consistently and correctly. Such methods include:\n   * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal\n   * Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable\n   * Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)\n   * Bilateral tubal occlusion\n   * Vasectomy of participant or participant's partner (with medical assessment and confirmation of vasectomy surgical success)\n   * Sexual abstinence (only if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments)\n\n   Hormonal contraception may be susceptible to interaction with study or other drugs, which may reduce the efficacy of the contraception method.\n\n   Abstinence (relative to heterosexual activity) can only be used as the sole method of contraception if it is consistently employed during the entire period of risk associated with the study treatments.\n\n   Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, and post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n9. Ability of patient to understand and the willingness to sign a written informed consent document.\n10. Any HIV status will be included in this study; status must be confirmed prior to enrollment.\n\nEXCLUSION CRITERIA:\n\n1. Patients who meet histologic criteria for the following subtypes are excluded:\n\n   * Primary DLBCL of the central nervous system (PCNSL)\n   * Primary mediastinal B-cell lymphoma (PMBL)\n   * Plasmablastic lymphoma\n   * Intravascular large B-cell lymphoma\n   * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n2. Patients who, at the discretion of the investigator, need immediate cytoreductive chemotherapy such as patients with evidence of spontaneous tumor lysis or impending organ compromise are not eligible.\n3. Current or prior anti-cancer treatment for DLBCL prior to enrollment. Short course of corticosteroids (\\\u003C7 days) for acute issues prior to study enrollment are permitted.\n4. Major surgical procedure within 30 days of first dose of study drug. If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n5. Requires treatment with moderate or strong CYP3A inhibitors or inducers\n6. Known lymphomatous involvement of the CNS\n7. Pregnant individuals, or individuals who intend to become pregnant during the study are excluded from this study because of potential teratogenic effects associated with acalabrutinib, R-CHOP, and\u002For DA-EPOCH-R\n8. The potential for all study treatments to be excreted in the milk of nursing mothers is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with acalabrutinib, nursing must be discontinued.\n9. Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n   -Other malignancy that requires ongoing systemic hormonal therapy, chemotherapy, or immunotherapy.\n\n   Uncontrolled active systemic infection\n   * Any condition that requires anticoagulation with warfarin or equivalent vitamin K antagonist\n   * Active bleeding, history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)\n   * Suspected or confirmed Progressive Multifocal Leukoencephalopathy (PML)\n   * Active hepatitis C infection. NOTE: Subjects who are hepatitis C antibody positive will need to have a negative HCV PCR result before enrollment. Those with a positive PCR for hepatitis C are excluded.\n   * Active hepatitis B infection. NOTE: Patients who are hepatitis B surface antigen (HbsAg) positive will be excluded from enrollment. Patients who are hepatitis B core antibody (HbcAb) positive will need to have a negative HBV PCR result before enrollment. Those with a positive PCR for hepatitis B are excluded. Those who are hepatitis B core antibody (HbcAb) positive with a negative PCR for hepatitis B will be treated with antivirals designed to prevent hepatitis B reactivation (e.g., entecavir) throughout therapy and for 12 months after therapy and have monitoring for hepatitis B reactivation with PCR.\n   * History of hemorrhagic stroke or intracranial hemorrhage in preceding 6 months\n   * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled atrial fibrillation\u002Fflutter during screening are eligible.\n   * Uncontrolled autoimmune hemolytic anemia\n   * Inability to swallow oral medications, or disease involve that significantly limits absorption of oral medication\n   * Known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n10. Concurrent participation in another therapeutic clinical trial.",{"count":233,"type":21},132,[53],"Background:\n\nDiffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate.\n\nObjective:\n\nTo see if the drug acalabrutinib given with rituximab and standard combination chemotherapy can improve the cure rate of aggressive B-cell lymphomas such as diffuse large B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with an aggressive B-cell lymphomas that have not been treated\n\nDesign:\n\nParticipants will be screened with:\n\nBlood and urine tests\n\nPhysical exam\n\nMedical history\n\nTumor biopsy\n\nBone marrow biopsy: A needle will remove marrow from the participant s hipbone.\n\nLumbar puncture: If necessary, a needle will remove fluid from the participant s spinal canal.\n\nImaging scans\n\nParticipants will take the study drug for up to 14 days. It is a pill taken 2 times a day. Then they will have more scans. They will get rituximab and chemotherapy. They may get these drugs through a needle in an arm vein. Or they may them through a tube placed in a vein in their chest or in their neck. They might also keep taking the study drug. Each treatment cycle lasts 21 days. They will have up to 6 cycles.\n\nParticipants may have 4 doses of another drug injected into their spinal fluid.\n\nParticipants will have repeats of the screening tests throughout the study.\n\nParticipants will have a follow-up visit 30 days after their last treatment, then every 3 months for 2 years, then every 6 months for 3 years, and then yearly.",[237,27,56,238],"Non-Hodgkin's Lymphoma","NHL",[240,241,242,181],"BTK Inhibitor","Calquence","ACP-196",{"date":244,"type":34},"2026-08-13",{"date":246,"type":34},"2019-08-05",{"date":248,"type":21},"2031-03-31",{"name":190,"class":191},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":266,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":116},"100507421","feasibility-and-safety-of-collecting-and-combining-autologous-hematopoietic-stem-cells-with-chimeric-antigen-receptor-car-t-cell-therapy-in-subjects-with-relapsedrefractory-hematological-malignancies-100507421","NCT05887167","Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed\u002FRefractory Hematological Malignancies","IIT2022-04-Sasine-CAR-T: A Phase 1 Single-arm, Open-label Study to Evaluate the Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n* Age 18 - 85 years.\n* Histologically proven hematological malignancy according to the World Health Organization 2016 classification criteria for which a commercially available, FDA-approved CAR T product exists.\n* Relapsed or refractory disease, defined by the following:\n\n  * Disease progression after last regimen, or\n  * Refractory disease: failure to achieve a partial response (PR) or complete remission (CR) to the last regimen\n* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy for the malignancy at the time the subject is planned for leukapheresis.\n* Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 with the exception of alopecia.\n* Subjects with an active uncontrolled infection should not start CAR T treatment until the infection has resolved.\n* Eastern cooperative oncology group (ECOG) performance status 0 - 2.\n* Adequate hematologic, hepatic, and cardiac function\n* Serum pregnancy test for women of childbearing potential (WOCBP) at Screening.\n* Willing to comply to research specimen collection as specified in the protocol.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Autologous hematopoietic cell transplant intent or execution within 8 weeks of planned CAR T infusion.\n* History of allogeneic cell transplantation within 8 weeks of planned CAR T infusion.\n* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management at time of screening.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.\n* History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, or any autoimmune disease with CNS involvement.\n* Doses of corticosteroids of greater than or equal to 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids and other immunosuppressive drugs are not allowed prior to enrollment. A washout period of 10 days prior to leukapheresis and 10 days prior to anti-CD19 CAR T cell administration is required.\n* Any medical condition likely to interfere with assessment of feasibility or safety of study treatment.\n* Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Current pregnancy or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.\n* Subjects of both sexes who are not willing to practice birth control from the time of consent through 6 months after the completion of conditioning chemotherapy. Females who have undergone surgical sterilization or who have been postmenopausal for at least 1 year are not considered to be of childbearing potential.\n* In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* Patients with obvious myeloid clonal hematopoiesis on the screening bone marrow biopsy will be excluded based on the risk of developing myeloid neoplasms with aHSC infusion.","85 Years",{"count":259,"type":21},20,[74],"The study is designed to examine the feasibility and safety of collecting autologous hematopoietic stem cells (HSCs) to be combined with CAR T-cell therapy for patients with relapsed\u002Frefractory (r\u002Fr) hematological disease. The study will evaluate feasibility of collecting the target dose of HSCs from at least 50% of enrolled patients. The study will assess safety based on incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in the first 60 days post CAR T dosing, and also through the collection of adverse events (AEs) and serious adverse events (SAEs) as well as the durability of response after treatment with HSCs with CAR T. The study follows an open-label, single-center and single non-randomized cohort design. 20 subjects with r\u002Fr hematological malignancies will be enrolled and treated to evaluate the feasibility and preliminary safety of collecting autologous HSCs and combining them with CAR T-cell therapy.",[263,264,106,84,265,85],"Hematologic Malignancy","Large B-cell Lymphoma","Multiple Myeloma",[267,268,269,270],"CAR T-cell therapy","autologous hematopoietic stem cells","CAR T","CAR T therapy","2026-08-06",{"date":273,"type":34},"2026-08-10",{"date":275,"type":34},"2024-03-02",{"date":277,"type":21},"2027-12-15",{"name":279,"class":115},"Joshua Sasine, MD, PhD",{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":17,"minAge":288,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},"100512405","phase-2-study-of-acalabrutinib-and-rituximab-in-untreated-elderly-andor-frail-patients-with-dlbcl-100512405","NCT05952024","Study of Acalabrutinib and Rituximab in Untreated Elderly and\u002For Frail Patients With DLBCL","A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and\u002For Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE)","ACRUE","Inclusion Criteria:\n\n* ≥ 80 years of age at the time of screening, or\n* ≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy\n* Histologically documented DLBCL\n* No prior treatment for DLBCL\n* Stage II, III, or IV disease by the Ann Arbor Classification .\n* Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma.\n* At least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements.\n* Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening.\n\nExclusion Criteria:\n\n* Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol.\n* History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results.\n* Serologic status reflecting active hepatitis B or C infection.\n* Serological positivity or known infection with HIV.\n* Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.\n* Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of \\> 17.\n* History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.\n* Known active significant infection.\n* History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug.\n* History of bleeding diathesis (eg, haemophilia, von Willebrand disease).\n* Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe.\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.\n* Received a live virus vaccination within 28 days of the first dose of study drug.","65 Years","99 Years",{"count":165,"type":21},[53],"The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and\u002For frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.",[27],[295,296],"Chemoimmunotherapy treatments","Treatment-naïve elderly patients","2026-08-05",{"date":271,"type":34},{"date":300,"type":34},"2024-07-16",{"date":302,"type":21},"2029-04-22",{"name":304,"class":41},"AstraZeneca",57,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":315,"phases":4,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100608347","an-observational-study-of-glofitamab-in-chinese-adult-participants-with-2l-diffuse-large-b-cell-lymphoma-100608347","NCT07200375","An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma","Evaluating Effectiveness and Safety of Glofitamab Based Second-Line Therapy in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Cohort Study","GlofitReal","Inclusion Criteria:\n\n* Histologically confirmed R\u002FR DLBCL after one line of systemic therapy\n* Will be treated with Glofit-based regimen (known as being recommended and having the intention to be treated with Glofitamab at the time of signing ICF) or have initiated Glofit-based regimen treatment within three months (90 days) prior to enrollment\n\nExclusion Criteria:\n\n* Participants who currently participate in or plan to participate in any interventional clinical trial",{"count":125,"type":21},"OBSERVATIONAL","This study will investigate how well glofitamab-based therapy works and how safe it is in Chinese adult participants with relapsed or refractory diffuse large B-cell lymphoma (R\u002FR DLBCL).",[27],"2026-08-04",{"date":271,"type":34},{"date":321,"type":34},"2025-09-29",{"date":323,"type":21},"2029-09-29",{"name":325,"class":41},"Hoffmann-La Roche",21,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":346,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100557089","phase-1-gene-therapy-for-cd19-positive-hematologic-malignancies-sentry-cd19-100557089","NCT06533579","Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","A Phase 1\u002F2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","Inclusion Criteria:\n\n* Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age\n* Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol\n* CD19-positive expression\n* AAV specified capsid total antibody \\\u003C1:400\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity\n* Chemotherapy given within the protocol-specified discontinuation timelines\n\nOther Inclusion\u002FExclusion criteria to be applied per protocol.","13 Years","90 Years",{"count":337,"type":21},32,[74,53],"This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.",[341,264,82,83,78,79,84,85,342,179,343,344,345],"B-cell Acute Lymphoblastic Leukemia","High-grade B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[347,348,142],"CD19-positive","Leukemia",{"date":271,"type":34},{"date":351,"type":34},"2025-05-30",{"date":353,"type":21},"2031-09",{"name":355,"class":41},"Vironexis Biotherapeutics Inc.",11,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":116},"100515358","phase-1-lv2019-car-t-cells-in-combination-with-pirtobrutinib-for-relapsed-refractory-b-cell-malignancies-100515358","NCT05990465","LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies","Phase I Study of LV20.19 CAR T-cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies","To facilitate rapid start of pirtobrutinib, there will be separate inclusion\u002Fexclusion for pirtobrutinib and LV20.19 CAR T-cells in addition to the general inclusion as outlined below.\n\nGeneral inclusion criteria for trial:\n\n1. Patients must be aged ≥18 years and \\\u003C81 years with relapsed or refractory B-cell non-Hodgkin Lymphoma (NHL).\n2. Diagnosis of relapsed or refractory B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, Burkitt Lymphoma and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV)+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n3. Disease specific criteria as follows:\n\n   1. DLBCL and associated subtypes (listed above)\n\n   i. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody with combination anthracycline based chemotherapy regimen and have ONE of the following:\n\n\u003C!-- -->\n\n1. Primary refractory lymphoma or early relapse ≤6 months after one line of therapy.\n2. For relapse \\>6.00 months, failure of two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n\nii. Relapse post-autologous transplant. iii. Relapse post-allogeneic transplant. iv. Relapse post-CAR T-cell therapy (maximum 2 patients allowed with this designation).\n\nb. Mantle Cell Lymphoma\n\ni. Must have received Rituximab or another CD 20 antibody with one chemotherapy regimen appropriate for this disease (bendamustine or cytarabine, or anthracycline based treatment) and have ONE of the following:\n\n1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody.\n2. Progressive disease after ≥second line BTK inhibitor.\n3. Relapse post-autologous transplant.\n4. Relapse post-allogeneic transplant.\n\n   c. Marginal Zone Lymphoma and Follicular Lymphoma\n\n   i. Must have received Rituximab or another CD20 antibody with chemotherapy regimen appropriate for the disease and have ONE of the following:\n\n\u003C!-- -->\n\n1. Relapsed disease after two lines of therapy including administration of anti-CD20 antibody.\n2. Relapse post-autologous transplant.\n3. Relapse post-allogeneic transplant.\n\n   d. Burkitt's Lymphoma\n\n   i. Must have received Rituximab or another CD20 antibody in combination with anthracycline based chemotherapy regimen and have ONE of the following:\n\n\u003C!-- -->\n\n1. Primary refractory lymphoma.\n2. Relapse within 6 months.\n3. For relapse \\>6 months, failure of two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n\n   i. Relapse post-autologous transplant. ii. Relapse post-allogeneic transplant.\n4. Able to provide written informed consent.\n5. Negative urine or serum pregnancy test in females of childbearing potential at screening.\n6. Willingness of women of reproductive potential and their partners to observe highly effective birth control methods for duration of treatment and for 1 month following the last dose if study treatment.\n7. Karnofsky performance score ≥70.\n8. Expected survival \\>12 weeks.\n9. Patient has demonstrated compliance with prior therapies.\n10. Able to take oral medications.\n11. Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x upper limit of normal (ULN).\n12. Patients are required to have the following washout periods prior to planned Cycle 1 Day 1 (C1D1). In addition, prior treatment-related adverse events (AEs) must have recovered to Grade ≤ 1 with the exception of alopecia and Grade 2 peripheral neuropathy.\n\n    1. Targeted agents, investigational agents, therapeutic monoclonal antibodies or cytotoxic chemotherapy: 5 half-lives or 2 weeks, whichever is shorter.\n    2. immunoconjugated antibody treatment within 10 weeks prior to randomization.\n    3. broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy) must be completed 14 days prior to study enrollment.\n    4. palliative limited field radiation must be completed 7 days prior to study enrollment.\n\nInclusion Criteria to START Pirtobrutinib Bridging:\n\n1. Absolute neutrophil count (ANC) ≥1000 with no G-CSF within 7 days or pegylated G-CSF within 14 days unless patient has biopsy proven bone marrow involvement.\n2. Platelets≥50,000 with no transfusion within 7 days unless patient has biopsy proven bone marrow involvement.\n3. Hemoglobin ≥8g\u002FdL (≥80 g\u002FL) \\[blood transfusions are allowable to reach this goal\\].\n4. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine transaminase (ALT) \\\u003C3 x upper limit of normal (ULN) or \\\u003C 5 x ULN with documented liver involvement; serum bilirubin \\\u003C1.5 x ULN or \\\u003C3 x ULN with documented liver involvement , or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n5. Adequate renal function, defined as creatinine clearance≥50 ml\u002Fmin.\n\n   1. No IV hydration within 24 hours of eligibility.\n   2. No dialysis dependent renal failure.\n\nInclusion criteria for Pirtobrutinib Maintenance (part B)\n\n1. Recovery of neutrophils count after CAR T-cell infusion with ANC ≥1000\u002FdL without G-CSF within the last 7 days.\n2. Recovery of platelet count after CAR T-cell infusion with platelet count ≥50,000\u002FdL.\n3. Adequate hepatic function, defined as back to baseline or AST and ALT \\\u003C3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C3 x ULN, or considered not clinically significant as per the clinical PI's discretion (e.g., Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n4. Adequate renal function, defined as creatinine clearance≥40 ml\u002Fmin.\n5. Evidence of response or stable disease (complete response\u002Fpartial response\u002Fstable disease) at day 28 after CAR T-cell therapy.\n\nInclusion Criteria for Apheresis and LV20.19 CAR T-cells:\n\n1. Active Measurable disease must be documented within 4 weeks of lymphodepletion start defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL.\n2. Absolute cluster of differentiation (CD) 3 count≥50 mm\\^3.\n3. MRI brain and Lumbar Puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment.\n4. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by echocardiogram (ECHO) or MUGA) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.\n5. No contraindication to central line access.\n6. ANC≥1000 with no pegylated G-CSF within 14 days unless patient has biopsy proven bone marrow involvement.\n7. Platelets≥50,000 with no transfusion within 72 hours unless patient has biopsy proven bone marrow involvement.\n8. Adequate hepatic function, defined as AST and ALT \\\u003C3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C3 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n9. Adequate renal function, defined as creatinine clearance≥50 ml\u002Fmin. a. No IV hydration within 24 hours of eligibility. b. No dialysis dependent renal failure.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential or plan to become pregnant during the study or within 1 month of the last dose of study treatment and women who are current lactating or plan to breastfeed during the study or within 1 week of the last dose of study treatment.\n2. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n   1. HBV: Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before randomization. Patients who are hepatitis B PCR positive will be excluded.\n   2. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded.\n3. Known active cytomegalovirus (CMV) infection (Unknown or negative status are eligible).\n4. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n5. Presence of ≥ grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n6. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.\n7. Refusal to participate in the long-term follow-up protocol.\n8. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture.\n\n   1. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \\>4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.\n9. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C100 days post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n10. Prior allogeneic CAR T-cell therapy \\\u003C100 days from prior CAR T-cell treatment.\n11. Previous recipients of autologous CAR-T cell therapy directed at either cluster of differentiation 19 (CD19) or CD20 are excluded if they are \\\u003C100 days post prior CAR-T cell treatment (does not include re-enrollment) or have \\>5% residual circulating CAR-T as measured by flow cytometry using a CD19 CAR detection reagent (Miltenyi Biotec).\n\n    a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry.\n12. Anti-CD20 antibody treatment within 4 weeks of cell infusion.\n13. Anti-CD19 antibody treatment within 4 weeks of cell infusion.\n14. Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells.\n15. No other oral chemotherapeutic agents or antibody directed treatment after starting pirtobrutinib other than steroids or radiation to a single site in a palliative fashion.\n16. Patients post solid organ transplant who develop high grade lymphomas or leukemias.\n17. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin (underlying low-grade lymphoma chronic lymphocytic leukemia\u002FFollicular lymphoma (FL) \u002F Marginal zone lymphoma (MZL) is allowable in patients with transformed large cell lymphoma\u002FRichter's.\n18. Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.\n19. History of stroke or intracranial hemorrhage within 6 months of randomization.\n20. Significant cardiovascular disease defined as myocardial infarction within 6 months of randomization, congestive heart failure with ejection fraction \\\u003C30%, active unstable angina, QT prolongation (QTcF)\\>470 msec on ECG.\n21. Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.\n22. Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.\n23. Patients who had surgery within 4 weeks prior to randomization.\n24. Patients who have received vaccination with live vaccine within 28 days prior to randomization.\n25. Patients with known hypersensitivity to any of the excipients of pirtobrutinib.\n\n    Special Criteria Regarding Fertility and Contraception\n\n    Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed at screening.\n\n    Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.\n\n    Acceptable birth control includes a combination of two of the following methods:\n\n    • Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n\n    • Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n\n    • Intrauterine device (IUD)\n\n    • Intrauterine hormone-releasing system (IUS)\n\n    • Vasectomized partner\n\n    • Sexual abstinence: considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence will be evaluated in relation to the duration of the study and to the usual lifestyles of the patient.\n\n    • Female sterilization\n\n    • Fallopian tube implants (if confirmed by hysterosalpingogram) Oocyte donation is prohibited during the duration of participation on this protocol and for 1 month after the last dose of study drug.\n\n    Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months which is non-therapy induced or have undergone hysterectomy tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.","81 Years",{"count":366,"type":21},12,[74],"This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.",[344,85,79,78,84,179],[371,372,373,374,375,376,377],"CAR-T","Chimeric antigen receptor T-cell therapy","CAR Therapy","Pirtobrutinib","B Cells","BTK inhibitor","Bruton's tyrosine kinase",{"date":271,"type":34},{"date":380,"type":34},"2025-02-06",{"date":382,"type":21},"2030-07",{"name":384,"class":115},"Medical College of Wisconsin",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":315,"phases":4,"briefSummary":394,"conditions":395,"keywords":403,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":116},"100650658","sample-collection-for-ongoing-research-and-product-evaluation-study---non-hodgkin-lymphoma-score-nhl-100650658","NCT07750886","Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL)","SCORE-NHL","Inclusion Criteria:\n\n1. Patient is at least 18 years of age or older.\n2. Eastern Cooperative Oncology Group performance status ≤ 2.\n3. Patients who are able to consent to and provide residual tumor tissue for research. Bone marrow specimens are excluded as acceptable tumor tissue.\n4. Patients with a new diagnosis of Stage I to IV aggressive non-Hodgkin lymphoma (NHL) including all aggressive large B-cell lymphoma (DLBCL, HGBCL, PMBCL), T-cell lymphoma (PTCL, ALCL), follicular lymphoma (FL) grade 3B, or transformed FL.\n5. Patients who are planning to receive six cycles of first-line therapy with an anthracycline-based chemotherapy regimen as per the standard of care.\n6. Radiographically measurable disease with at least one hypermetabolic lesion by Lugano classification on baseline FDG PET\u002FCT or FDG PET (radiographically measurable disease by CT with intravenous contrast is allowed if FDG-PET\u002FCT is not available).\n7. Able to tolerate blood draws according to Natera standard process.\n\nExclusion Criteria:\n\n1. Diagnosis of an indolent lymphoma that does not require immediate intervention, Hodgkin lymphoma, small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL). Other NHL diagnoses beyond DLBCL, aggressive TCLs, and grade 3B or transformed FL.\n2. Diagnosis of aggressive NHL that has a circulating, leukemic component, bone marrow or blood involvement.\n3. History of an allogeneic stem cell transplant or other organ transplant.\n4. Prior history and treatment for any cancer within the past year or another active cancer, with the exception of participants who have undergone surgical removal of skin squamous cell or basal cell cancers.\n5. Clinical ctDNA-MRD testing by any platform.\n6. Concurrent treatment that includes an investigational agent.",{"count":393,"type":21},200,"The SCORE-NHL study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with aggressive Stage I to IV non-Hodgkin Lymphoma (NHL). Study participants will undergo research blood collections of up to 60 mL as well as residual tissue collection, collected as part of a standard of care procedure, for use in research. Collected samples and data will be analyzed to evaluate biomarkers associated with development and validation of cancer monitoring and detection assays (\"Natera cancer monitoring and detection test(s)\").",[80,396,27,397,398,399,400,401,79,402],"T-Cell Lymphoma","High-Grade B-Cell Lymphoma","Primary Mediastinal B-Cell Lymphoma","Peripheral T-Cell Lymphoma","Transformed Follicular Lymphoma","Follicular Lymphoma Grade 3B","Anaplastic Large Cell Lymphoma",[80,396,85,398,399,402,400,404,79,238,56,405,397,406,407,408,409],"Follicular Lymphoma grade 3B","HGBCL","PMBCL","PTCL","FL","ALCL","2026-08-03",{"date":271,"type":34},{"date":413,"type":21},"2026-07-27",{"date":415,"type":21},"2032-04",{"name":417,"class":41},"Natera, Inc.",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":434,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":454},"100194258","phase-3-a-long-term-extension-study-of-pci-32765-ibrutinib-100194258","NCT01804686","A Long-term Extension Study of PCI-32765 (Ibrutinib)","PCI-32765CAN3001: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study","CAN3001","Inclusion Criteria:\n\n* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib\n* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks\n* Agrees to protocol-defined use of effective contraception\n* Negative blood or urine pregnancy test at screening\n\nExclusion Criteria:\n\n* Requires anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with strong cytochrome P450 (CYP)3A4\u002F5 inhibitors, unless previously approved by sponsor\n* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study",{"count":427,"type":21},700,[24],"The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.",[82,83,84,79,431,432,433],"Diffuse Large B-cell Lymphoma","Waldenstrom Macroglobulinemia","Chronic Graft Versus Host Disease",[435,436,437,438,439,440,441,442,443,444],"Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Mantle cell lymphoma","Follicular lymphoma","Diffuse large B-cell lymphoma","PCI-32765","Ibrutinib","Bruton's tyrosine kinase inhibitor","IMBRUVICA","JNJ-54179060","2026-07-30",{"date":447,"type":34},"2026-07-31",{"date":449,"type":34},"2013-09-09",{"date":451,"type":21},"2029-12-31",{"name":453,"class":41},"Janssen Research & Development, LLC",175,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":469,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":484},"100467353","phase-1-iks03-in-patients-with-advanced-b-cell-non-hodgkin-lymphomas-100467353","NCT05365659","IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas","A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (NHL)","Inclusion Criteria:\n\n1. Males or females, ≥ 18 years of age\n2. Part I: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible\n3. Part II: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include:\n\n   1. Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)\n   2. Follicular lymphoma (including duodenal-type follicular lymphoma)\n   3. Mantle cell lymphoma\n   4. B cell lymphomas not specified\n4. If B cell NHL subtype likely to have bone marrow involvement must be willing to undergo bone marrow biopsy in the event of an on-study complete response to confirm response\n5. NHL that is relapsed, refractory to, or intolerant of existing therapy(ies) with known curative potential, or for which no standard therapy is available; must have received at least 2 prior lines of systemic therapy\n6. Must be in need of systemic treatment and not require immediate cytoreductive therapy\n7. Part I: measurable or non-measurable disease\n8. Part II: measurable disease according to The Revised Criteria\u002FLugano Classification\n9. Part I: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy\n10. ECOG performance status 0 or 1\n11. Women of childbearing potential and fertile men agreeing to use two effective methods of contraception (including a highly effective method of contraception); women beginning 2 weeks prior to the first dose, men beginning prior to the first dose, and both continuing until 8 months after the last dose of study drug; male patients must also agree to refrain from sperm donation during this period.\n12. Ability to understand and give written informed consent\n\nExclusion Criteria:\n\n1. Women who are pregnant or intending to become pregnant before, during, or within 8 months after the last dose of study drug; women who are breastfeeding\n2. Patients documented to be CD19-negative\n3. Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy; symptoms suggesting CNS involvement\n4. Part 2: History of another malignancy within 2 years, with the exception of:\n\n   1. Treated, non-melanoma skin cancers\n   2. Treated carcinoma in situ (e.g., breast, cervix)\n   3. Controlled, superficial carcinoma of the urinary bladder\n   4. T1a or b prostate carcinoma treated according to standard of care, with PSA within normal limits\n   5. Papillary thyroid carcinoma Stage I treated surgically for cure\n5. Any of the following hematologic abnormalities at baseline (transfusion allowed \\> 5 days previous):\n\n   1. Hemoglobin \\\u003C 8.0 g\u002FdL\n   2. Absolute neutrophil count \\\u003C 1,000 per mm3\n   3. Platelet count \\\u003C 75,000 per mm3\n6. Any of the following laboratory abnormalities at baseline:\n\n   1. Total bilirubin \\> 1.5 × upper limit of normal (ULN); \\> 3 × ULN if with Gilbert's Syndrome\n   2. AST or ALT \\> 3 × ULN; \\> 5 × ULN if due to hepatic involvement by tumor\n   3. Estimated GFR ≤ 60 mL\u002Fmin corrected for BSA\n   4. Albuminuria defined as urine albumin to creatinine ratio \\\u003C 30 mg\u002Fg or \\\u003C 3 mg\u002Fmmol) by spot urine albumin\n7. Any of the following coagulation parameter abnormalities at baseline unless on a stable dose of anticoagulant therapy for a prior thrombotic event:\n\n   1. PT or INR \\> 1.5 × ULN; \\> 3× ULN if anticoagulated)\n   2. PTT \\> 1.5 × ULN; \\> 3× ULN if anticoagulated\n8. Any of the following laboratory abnormalities at baseline aimed at assessing renal function:\n\n   1. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin, corrected for BSA.\n   2. Albuminuria defined as urine albumin to creatinine ratio (UACR) ≥ 45 mg\u002Fg or ≥ 4.5 mg\u002Fmmol by spot urine albumin\n9. Patients with:\n\n   1. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks unless adequately treated and stable\n   2. Active uncontrolled bleeding or a known bleeding diathesis\n10. Significant cardiovascular disease or condition, including:\n\n    1. Congestive heart failure or angina pectoris requiring therapy\n    2. Ventricular arrhythmia requiring therapy or other uncontrolled arrhythmia\n    3. Severe conduction disturbance (e.g., 3rd degree heart block)\n    4. QTc interval ≥ 480 milliseconds\n    5. Left ventricular ejection fraction below the lower limit of normal or \\\u003C 50% by MUGA scan or echocardiogram\n    6. Class III or IV cardiovascular disease according to the New York Heart Association Functional Classification\n    7. History of acute coronary syndromes (e.g., MI, unstable angina), coronary angioplasty, stenting, or bypass within 6 months\n11. Significant liver disease, including:\n\n    1. Non-infectious hepatitis\n    2. Hepatic cirrhosis (Child-Pugh Class B and Class C)\n12. Significant pulmonary disease or condition, including:\n\n    1. Significant symptomatic COPD, as assessed by the Investigator\n    2. History or any current evidence on imaging studies of interstitial lung disease, pulmonary fibrosis\n    3. History of pulmonary inflammatory disease, pneumonitis, ARDS\n    4. History of pneumonia within 1 month\n13. Significant corneal disease or condition, including history of or current evidence of keratitis\n14. Clinically significant CNS disease or condition including PML, epilepsy, vasculitis, or neurodegenerative disease. Also including TIA or stroke within 6 months\n15. Known HIV infection or AIDS\n16. Active hepatitis B virus or hepatitis C virus infection\n17. Any other serious\u002Factive\u002Funcontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \\> 38ºC within 2 weeks\n18. Autoimmune disease or condition requiring systemic steroids or other immunosuppressive medications\n19. Unresolved Grade \\> 1 AE associated with any prior antineoplastic therapy (except persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, neutropenia, lymphopenia, hypomagnesemia, and\u002For endocrine end-organ failure being adequately managed by HRT)\n20. Known or suspected hypersensitivity to any of the excipients of formulated study drug\n21. Inadequate recovery from a surgical procedure, or a major surgical procedure within 4 weeks\n22. Any other serious, life-threatening, or unstable preexisting medical condition, including significant organ system dysfunction, or clinically significant laboratory abnormality(ies)\n23. A psychiatric disorder or altered mental status that would preclude understanding of the informed consent process\n\nDrugs and Other Treatments to be Excluded:\n\n1. Receipt of:\n\n   1. Any CD19-targeted therapy within 4 weeks\n   2. Any tumor vaccine within 6 weeks (must have progressed if previously received)\n2. Prior autologous\u002Fallogeneic CAR-T therapy if known to be CD19-negative after\n3. Any other antineoplastic agent for the primary malignancy without delayed toxicity within 3 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)\n4. Any other investigational treatments within 3 weeks\n5. Drugs known to impair renal function, including:\n\n   1. NSAIDS within 3 days\n   2. Aminoglycoside antibiotics, amphotericin B, etc. within 1 week\n   3. Bisphosphonates within 1 month\n6. Prior solid organ transplant\n7. Allogeneic HSCT within 6 months, or:\n\n   1. If receiving immunosuppression\n   2. If with active evidence of GVHD\n8. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months\n9. Radiotherapy:\n\n   1. To target lesions within 4 weeks unless progression of the lesion has been documented\n   2. To non-target lesions within 1 week\n10. Live\u002Flive-attenuated vaccines against infectious diseases within 4 weeks\n11. Immunosuppressive or systemic glucocorticoid therapy (\\> 10 mg prednisone daily or equivalent) within 2 weeks\n12. Prophylactic use of hematopoietic growth factors within 1 week\n13. Herbal therapies and supplements within 2 weeks\n14. Strong inhibitors of cytochrome P450 within 2 weeks",{"count":463,"type":21},140,[74],"This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).",[467,85,79,84,468],"B-cell Non-Hodgkin Lymphoma","B-cell Lymphoma",[470,471,238,56,472,473,474,475],"CD19","non-Hodgkin lymphoma","MCL","advance lymphoma","IKS03","lymphoma",{"date":477,"type":34},"2026-07-29",{"date":479,"type":34},"2023-09-05",{"date":481,"type":21},"2028-09",{"name":483,"class":41},"Iksuda Therapeutics Ltd.",13,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":492,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":508},"100546451","phase-1-substudy-01a-zilovertamab-vedotin-in-pediatric-and-young-adult-participants-with-hematologic-malignancies-or-solid-tumors-mk-9999-01alightbeam-u01-100546451","NCT06395103","Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A\u002FLIGHTBEAM-U01)","LIGHTBEAM-U01 Substudy 01A: A Phase 1\u002F2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL\u002FBurkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.\n* For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.\n\nExclusion Criteria:\n\n* History of solid organ transplant.\n* Clinically significant (ie, active) cardiovascular disease.\n* Known history of liver cirrhosis.\n* Ongoing Grade \\>1 peripheral neuropathy.\n* Demyelinating form of Charcot-Marie-Tooth disease.\n* Diagnosed with Down syndrome.\n* Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.\n* History of human immunodeficiency virus (HIV) infection.\n* Contraindication or hypersensitivity to any of the study intervention components.\n* Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.\n* Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).\n* Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and\u002For cytoreductive therapy with steroids\u002Fhydroxyurea.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Known additional malignancy that is progressing or has required active treatment within the past 1 year.\n* Active infection requiring systemic therapy.\n* Known history of Hepatitis B or known active Hepatitis C virus infection.\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.","6 Months","25 Years",{"count":495,"type":21},90,[74,53],"Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)\u002FBurkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.",[341,431,179,499,500],"Neuroblastoma","Ewing Sarcoma","2026-07-24",{"date":413,"type":34},{"date":504,"type":34},"2024-08-16",{"date":506,"type":21},"2029-03-31",{"name":40,"class":41},71,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":525,"leadSponsor":527,"locationsCount":116},"100582445","phase-2-nemtabrutinib-and-pembrolizumab-for-the-treatment-of-richter-transformation-diffuse-large-b-cell-lymphoma-subtype-100582445","NCT06863402","Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype","Nemtabrutinib and Pembrolizumab in Patients With Richter Transformation: A Phase II Study","Inclusion Criteria:\n\n* Patients with biopsy-proven Richter transformation, diffuse large B-cell lymphoma subtype (RT-DLBCL) from an antecedent or concurrently diagnosed chronic lymphocytic leukemia (CLL) and\u002For small lymphocytic lymphoma (SLL).\n* Be ineligible for frontline anthracycline-based chemoimmunotherapy (determined by treating investigator) OR have clinical evidence of disease progression after any prior treatment for RT-DLBCL.\n* Participants who have adverse events (AEs) due to previous anti-cancer therapies must have recovered to ≤ grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤ grade 2 neuropathy are eligible.\n\n  * Note: Participants who have lingering cytopenias from prior anti-cancer therapy or progressive disease may be eligible at the discretion of the study principal investigator (PI), provided they meet all other study criteria.\n* Have measurable disease as determined by imaging (by positron-emission tomography \\[PET\\] and\u002For computed tomography \\[CT\\] scans), immunohistochemistry, and\u002For flow cytometry, as per the Cheson criteria.\n* Have the ability to swallow and retain oral medication.\n* Age 18 years and older on the day of signing informed consent.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Be free from other malignancy within 2 years prior to enrollment (with the exception of CLL\u002FSLL, low-risk and early stage \\[T1-T2a- Gleason score ≤ 6, and prostate-specific antigen \\[PSA\\] \\\u003C 10 ng\u002FmL\\] prostate cancer, or localized skin cancer that has undergone potentially curative therapy).\n* Absolute neutrophil count: ANC ≥ 500 cells\u002FµL (without G-CSF dose within the last 7 days prior to initiation of study treatment\n* Platelets: ≥ 25,000\u002FµL -not requiring transfusion within the last 3 days prior to initiation of study treatment). Patients on medications that increase bleeding risk (e.g. systemic anticoagulation, anti-platelet therapies, etc.) must have a platelet count ≥50,000 \u002FµL and have no history of major bleeding.\n* Hemoglobin: ≥ 7gm\u002FdL (transfusion support allowed).\n* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 x ULN.\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \\[SGPT\\]): ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases).\n* Creatinine clearance (CrCl): ≥ 30 mL\u002Fmin (per Cockroft-Gault equation).\n* International normalized ratio (INR) (prothrombin \\[PT\\]\u002Factivated partial thromboplastin time \\[aPTT\\]): ≤ 1.5 x ULN, unless participant is receiving anticoagulant therapy, as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n* Patients with history of human immunodeficiency virus (HIV) infection are potentially eligible (after conferring with the PI) if they meet ALL of the following criteria:\n\n  * Must have a CD4+ T-cell count ≥ 350 cells\u002Fmm\\^3 AND an HIV viral load below the detectable level as per locally available testing at the time of screening\n  * It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  * Participants on anti-retroviral therapy (ART) must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (day 1) and agree to continue ART throughout the study.\n  * The combination ART regimen must not contain any antiretroviral medications that interact with strong CYP3A4 inhibitors\u002Finducers\u002Fsubstrates (\\\u003Chttps:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers\\>). Participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n\nNote: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests, including HBsAg and hepatitis B core antibodies (anti-HBc), are required for all participants.\n\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening (Participants must have completed curative anti-viral therapy at least 4 weeks prior to the first administration of the study treatment).\n* A person of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Participants of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Should a person of child-bearing potential become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).\n* Has received prior systemic anti-cancer therapy within 5 half-lives or 14 days, whichever is lesser (or within 30 days for cellular therapy or investigational agents, or within 100 days post allogeneic hematopoietic stem cell transplantation and without any grade ≥ 2 graft versus host disease) prior to enrollment.\n* Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system (CNS) disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed or messenger ribonucleic acid (mRNA) vaccines is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (daily dose exceeding 10 mg of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. Has severe hypersensitivity (≥ grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has severe hypersensitivity (≥ grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid allowed).\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients with pathologically confirmed Hodgkin-like RT (RT-classical Hodgkin's lymphoma \\[cHL\\]).\n* Estimated life expectancy of \\\u003C 1 month as determined by the treating investigator.\n* Uncontrolled active illness including but not limited to heart failure, unstable ischemic heart disease, arrhythmia, psychiatric illness, acute renal failure, and any other conditions that would reasonably be expected to limit compliance with the study protocol.\n* Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV deoxyribonucleic acid \\[DNA\\]) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n* Corrected QT interval (QTc) prolongation (defined as a Fridericia's corrected QT \\[QTcF\\] \\> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin).\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Unwilling or unable to follow protocol requirements.\n* Received any other investigational agent within 30 days prior to enrollment.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For multicentric Castleman's disease.\n* History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding.NOTE: Patients on active anti-coagulation, anti-platelet therapies, and other medications that may increase bleeding risks may be allowed on study, permitted that these potentially interacting drugs may be safely held in the setting of thrombocytopenia, and at the discretion of the treating investigator and with close monitoring.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has had an allogeneic tissue\u002Fsolid organ transplant. Note: Patients with prior allogeneic hematopoietic stem cell transplant or allogeneic cellular therapy are allowed, provided they meet they meet the washout period.\n* Use of medications that are strong CYP3A4 inhibitors or inducers or P-gp and\u002For BCRP substrates with a narrow therapeutic index within 14 days prior to first dose of study treatment or 5 half-lives of the given drug, whichever is longer",{"count":337,"type":21},[53],"This phase II trial tests how well nemtabrutinib in combination with pembrolizumab works in treating patients with Richter transformation, diffuse large B-cell lymphoma subtype (RT-DLBCL). Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cells (a type of white blood cell) in cancers such as Richter transformation at abnormal levels. This may help keep cancer cells from growing and spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving nemtabrutinib in combination with pembrolizumab may kill more cancer cells in patients with RT-DLBCL.",[520,27,82],"Richter Syndrome","2026-07-17",{"date":523,"type":34},"2026-07-20",{"date":183,"type":21},{"date":526,"type":21},"2030-06-01",{"name":528,"class":115},"Roswell Park Cancer Institute",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":536,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":116},"100647851","phase-1-epcoritamab-and-pola-r-mini-chp-for-the-treatment-of-diffuse-large-b-cell-lymphoma-in-elderly-or-unfit-patients-100647851","NCT07714421","Epcoritamab and Pola-R-mini-CHP for the Treatment of Diffuse Large B Cell Lymphoma in Elderly or Unfit Patients","A Phase I Study of Single Agent Epcoritamab Followed by Epcoritamab Plus Pola-R-Mini-CHP for Elderly\u002FUnfit Patients With Previously Untreated DLBCL","Inclusion Criteria:\n\n* Previously untreated, histologically confirmed DLBCL according to World Health Organization (WHO) 2016 classification\n\n  * Documented CD20+ mature B-cell neoplasm according to WHO classification (Swerdlow et al., 2016) or WHO classification (WHO, 2008) based on representative pathology report\n\n    * Diffuse large B-cell lymphoma note: Other double-\u002Ftriple-hit lymphomas are not eligible\n  * Untreated patients who transform from low grade marginal zone lymphoma (MZL)\n  * Other aggressive B-non-hodgkin lymphoma (NHL):\n\n    * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL)\n    * High-grade B-cell lymphoma\n    * Newly diagnosed follicular lymphoma grade 3B (FL 3B)\n* At least one bi-dimensionally measurable nodal lesion, defined as \\> 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \\> 1.0 cm in its longest diameter\n* Age \\> 80 years, or age 70-79 years and not considered a candidate for full-dose aggressive chemotherapy (R-CHOP) with at least one of the following:\n\n  * Impairment in \\> 2 activity of daily living (ADL) component and\u002For\n  * Impairment in \\> 2 instrumental activity of daily living (IADL) component and\u002For\n  * Cumulative Illness Rating Scale for Geriatrics (CIRS-G) score of at least 1 comorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in \\> 8 comorbidities.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Life expectancy of at least 24 weeks\n* No significant pulmonary comorbidities (e.g., history of pneumonitis, severe chronic obstructive pulmonary disease \\[COPD\\])\n* Left ventricular ejection fraction ≥ 45%\n* Creatinine clearance \\> 40 mL\u002Fmin\n\n  * Exceptions may be made for patients with creatinine clearance \\\u003C 40 mL\u002Fmin, provided creatinine is within normal range\n* Hemoglobin \\> 9 g\u002FdL\n* Absolute neutrophil counts ≥ 1.0 × 10\\^9\u002FL; growth factor support allowed in case of bone marrow involvement\n* Platelet counts ≥ 75 × 10\\^9\u002FL or, in the presence of bone marrow involvement or splenomegaly, ≥ 50 × 10\\^9\u002FL\n* Lymphocyte counts \\\u003C 5 × 10\\^9\u002FL\n* If receiving glucocorticoid treatment at screening, must be a maximum daily dose of prednisone 100 mg (or equivalent) and a total of no more than 140 mg over the last 14 days prior to the first dose of epcoritamab, unless for disease control\n* Before the first dose of epcoritamab, during the trial and for 12 months after last administration of epcoritamab, a woman must be either:\n\n  * Not of childbearing potential: premenarchal; postmenopausal (\\> 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \\[FSH\\] level \\> 40 IU\u002FL or milli-International unit mIU\u002FmL); permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy\n* A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (that is the use of condom) during the trial and for 12 months after receiving the last dose of epcoritamab\n* COVID-19 ELIGIBILITY CRITERIA: Subject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection\n* COVID-19 ELIGIBILITY CRITERIA: If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction \\[PCR\\]) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection.\n\n  * Note: SARS-CoV-2 diagnostic tests should be applied following local requirements\u002Frecommendations\n* COVID-19 ELIGIBILITY CRITERIA: Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:\n\n  * No signs\u002Fsymptoms suggestive of active SARS-CoV-2 infection\n  * Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart\n* COVID-19 ELIGIBILITY CRITERIA: Patients with SARS-CoV-2 antigen or PCR testing positivity within 30 days prior to cycle 1 day 1 are not eligible\n* COVID-19 ELIGIBILITY CRITERIA: Any patient with documented SARS-CoV-2 infection within 6 months prior to planned cycle 1 day 1 must have no persistent respiratory symptoms, no evidence of residual sequelae, and a negative PCR test for SARS-CoV-2\n* COVID-19 ELIGIBILITY CRITERIA: Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to the first dose of epcoritamab, including COVID-19 infection. Note that a past COVID-19 infection may be a risk factor, but if resolved and the subject is vaccinated, it may be allowable to enroll the subject\n\nExclusion Criteria:\n\n* Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy\n\n  * Exception: patients who are treated with prednisone as part of pre-phase treatment\n* Current grade \\> 1 peripheral neuropathy by clinical examination\n* Known or suspected chronic active Epstein-Barr virus infection\n* Subjects that have transformed from indolent (i) NHL, who have previously been treated with an anthracycline-containing regimen or a CD3-CD20 bispecific antibody\n* Patients with known history or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening as confirmed by mandatory magnetic resonance imaging (MRI)\u002Fcomputed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture\n* Aspartate aminotransferase (AST), and\u002For alanine aminotransferase (ALT) \\> 3 × upper limit of normal (within 14 days of initiation of study treatment)\n* Total bilirubin \\> 1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin (within 14 days of initiation of study treatment)\n\n  * Patients with a documented history of Gilbert syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible\n* International normalization ratio (INR) \\> 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation (within 14 days of initiation of study treatment)\n* Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) \\> 1.5 x ULN in the absence of a lupus anticoagulant or therapeutic anticoagulant (within 14 days of initiation of study treatment)\n* Estimated creatinine clearance (CrCl) \\\u003C 40 mL\u002Fmin (within 14 days of initiation of study treatment)\n* Known clinically significant cardiovascular disease or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm) including:\n\n  * Unstable arrhythmias\n  * Onset of unstable angina pectoris within 6 months of signing informed consent form (ICF)\n  * Acute myocardial infarction within 6 months of signing ICF\n  * Congestive heart failure (New York Heart Association Class III or IV cardiac disease and\u002For known decrease ejection fraction of \\\u003C 45%)\n  * Stroke or intracranial hemorrhage within 6 months prior to signing ICF\n  * In case of any history of cardiovascular disease, a cardiology consult is required within 60 days of enrollment.\n  * For patients who are ≥ 75 years old, 2 or more active cardiovascular diseases (any type, ≥ grade 2)\n* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy including, but not limited to, myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n* Low-dose (≤ 10 mg\u002Fday) prednisolone (or equivalent) for rheumatoid arthritis or similar conditions is allowed\n* Received systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment \\\u003C 10 mg\u002Fday prednisone or equivalent within 2 weeks prior to first the dose of study drug\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology)\n\n  * Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus DNA is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated\n* Acute or chronic hepatitis C virus (HCV) infection\n\n  * Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction\n* Known human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4) count greater than 200 cells\u002FµL; HIV testing is required at screening only if required per local health authorities or institutional standards\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or early-stage localized prostate cancer (Gleason score \\\u003C 6 or below, Stage I or II) with no requirement for therapy at any time prior to study are eligible.\n  * Patients with a malignancy that has been treated with curative intent will also be excluded unless the malignancy has been in documented remission without treatment for \\> 2 years before enrollment. Exception will be made for patients with a history of breast cancer that is estrogen receptor-\u002Fprogesterone receptor-positive for more than 2 years before enrollment who are treated with adjuvant hormonal therapy\n* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks before cycle 1 day 1 (C1D1)\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Recent major surgery within 4 weeks before the start of C1D1\n* Superficial lymph node biopsies for diagnosis is allowed","70 Years",{"count":259,"type":21},[74],"This phase I trial tests the safety, side effects and best dose of epcoritamab alone and epcoritamab with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R- mini-CHP) for the treatment of diffuse large B cell lymphoma (DLBCL) in elderly or unfit patients. Epcoritamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell receptors, and delivers monomethyl auristatin E to kill them. Rituximab is a monoclonal antibody. It binds to a protein called cluster of differentiation antigen 20 (CD20), which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Epcoritamab alone and epcoritamab with pola-R-mini-CHP may be safe, tolerable and\u002For effective in treating DLBCL in elderly or unfit patients.",[27,541,542,543,544],"Grade 3b Follicular Lymphoma","High Grade B-Cell Lymphoma","Primary Mediastinal Large B-Cell Lymphoma","Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma","2026-07-15",{"date":523,"type":34},{"date":548,"type":21},"2026-12-08",{"date":550,"type":21},"2031-10-08",{"name":552,"class":115},"Jonsson Comprehensive Cancer Center",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":560,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":4},"100645448","phase-2-a-study-of-polatuzumab-vedotin-and-glofitamab-in-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-within-12-months-after-r-chop-100645448","NCT07702851","A Study of Polatuzumab Vedotin and Glofitamab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Within 12 Months After R-CHOP","A PROSPECTIVE MULTICENTER PHASE 2 STUDY OF THE CHEMOTHERAPY-FREE COMBINATION OF POLATUZUMAB VEDOTIN AND GLOFITAMAB IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA WITHIN 12 MONTHS OF R-CHOP TREATMENT","Inclusion Criteria:\n\n1. Histologically proven DLBCL\n2. Relapsed or refractory disease after first-line chemoimmunotherapy containing both rituximab and anthracycline A.Refractory disease defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded\n\n   * Progressive disease (PD) as best response to first-line therapy\n   * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n   * Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease or disease B.Relapsed disease defined as complete remission to first-line therapy followed by biopsy- proven disease relapse ≤ 12 months of initiating first-line therapy\n3. Signed Informed Consent Form\n4. Age ≥ 19 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures\n5. Life expectancy ≥ 12 weeks\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2\n7. At least one bi-dimensionally measurable (≥ 1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥ 1 cm) extranodal lesion, as measured on CT scan\n8. Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test within 7 days prior to enrollment\n9. Negative HIV test at screening, with the following exception:\n\n   i.Individuals with a positive HIV test at screening are eligible provided, prior to enrollment, they are stable on antiretroviral therapy, have a CD4 count ≥ 200\u002FµL, and have an undetectable viral load.\n10. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, as defined below:\n\n    i.Female participants must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 18 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab, 9 months after the final dose of polatuzumab vedotin, and 3 months after the final dose of tocilizumab (as applicable), whichever is longer. Women must refrain from donating eggs during this same period ii.A female participant is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n\n    iii.Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\n    Hormonal contraceptive methods must be supplemented by a barrier method. iv.The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n11. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, as defined below:\n\n    i.With a female partner of childbearing potential or pregnant female partners, male participants must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 3 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab, 6 months after the final dose of polatuzumab vedotin, or 2 months after the last dose of tocilizumab (as applicable), whichever is longer. Male participants must refrain from donating sperm during this same period.\n\n    ii.The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n12. Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by LBCL per the investigator for which blood product transfusions are permitted) defined as follows:\n\n    * Hemoglobin ≥ 9.0 g\u002FdL without packed RBC transfusion during 7 days before first treatment.\n    * ANC ≥1.0x109\u002FL\n    * Platelet count ≥75 x 109\u002FL\n13. Adequate renal function, defined as measured or estimated creatinine clearance ≥50 mL\u002Fmin\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from study entry:\n\nContraindication to any of the individual components of glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n\n1. Prior solid organ transplantation\n2. Prior treatment with a regimen containing polatuzumab vedotin or glofitamab\n3. Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune\u002Fcytokines and monoclonal antibodies (mAbs) (e.g., anti-cytotoxic T lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1) within 4 weeks or five half-lives of the drug, whichever is shorter\n4. Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1\n5. Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1\n6. Prior radiotherapy to the mediastinal\u002Fpericardial region(Radiotherapy to non-target lesion sites will be permitted.)\n7. Current Grade \\> 1 peripheral neuropathy\n8. Corticosteroid use \\> 50 mg\u002Fday of prednisone or equivalent, for purposes other than lymphoma symptom control i.Participants receiving corticosteroid treatment with ≤ 50 mg\u002Fday of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of Cycle 1.\n\n   * Corticosteroid therapy for control of cancer symptoms or side effects of prior treatment (e.g., nausea or B-symptoms) is permitted\n   * The use of inhaled corticosteroids is permitted.\n   * The use of mineralocorticoids for management of orthostatic hypotension is permitted.\n   * The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.\n\n   ii.Participants who require lymphoma symptom control during screening may receive steroids in the following manner:\n   * Up to 50 mg\u002Fday of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment).\n   * If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of \\> 30-100 mg\u002Fday of prednisone or equivalent. Prednisone \\> 30-100 mg\u002Fday or equivalent may be given for a maximum of 10-14 days as a pre-phase treatment. As part of the pre-phase treatment, vincristine may not be administered.\n9. History of other malignancy that could affect compliance with the protocol or interpretation of results:\n\n   i.Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.\n\n   ii.Participants with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≤ 2 years prior to enrollment are eligible.\n\n   iii.Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible.\n10. Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 3 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina\n11. Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis\n12. Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease i.Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits, as judged by the investigator, are allowed.\n13. Current or past history of CNS lymphoma\n14. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n15. Current or past history of Waldenström macroglobulinemia\n16. History or presence of an abnormal ECG that is clinically significant in the investigator's opinion\n17. Patients with known or suspected active infection, or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, SARS-Cov-2, Epstein-Barr virus (EBV), cytomegalovirus (CMV), hepatitis B, and hepatitis C), fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of dosing\n18. History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:\n\n    i.Grade ≥ 3 adverse events with the exception of Grade 3 endocrinopathy managed with replacement therapy.\n\n    ii.Grade 1\u002F2 adverse events that did not resolve to baseline after treatment discontinuation.\n19. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis i.Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.\n\n    ii.Participants with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible for this study.\n\n    iii.Participants with controlled Type I diabetes mellitus who are on an insulin regimen are eligible for the study.\n\n    iv.Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible (e.g., participants with psoriatic arthritis are excluded) if all the following conditions are met:\n    * Rash covers \\\u003C 10% of body surface area.\n    * Disease is well controlled for the last 12 months and requires only low-potency topical corticosteroids.\n20. Clinically significant liver disease, including active viral or other hepatitis or cirrhosis\n21. Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment\n22. Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):\n\n    * INR or PT \\>1.5 Xupper limit of normal (ULN) in the absence of therapeutic anticoagulation.\n    * PTT or aPTT \\> 1.5 XULN in the absence of a lupus anticoagulant.\n    * Serum AST and ALT ≥ 2.5 XULN\n    * Total bilirubin ≥ 1.5XULN Participants with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0XULN\n23. Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover, are prohibited Influenza vaccination should be given during influenza season only. Participants must not receive live, attenuated influenza vaccine at any time during the study treatment period.\n24. Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)\n25. Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology) Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated.\n26. Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing) Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n27. Participants with a history of progressive multifocal leukoencephalopathy\n28. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after pretreatment with obinutuzumab or 2 months after the final dose of glofitamab, whichever is longer\n29. Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable","19 Years",{"count":562,"type":21},47,[53],"Patients with diffuse large B-cell lymphoma (DLBCL) who are primary refractory to first-line R-CHOP therapy or relapse within 12 months after R-CHOP have a poor prognosis and limited treatment options. Conventional salvage chemotherapy has limited efficacy, and CAR-T cell therapy may be limited by manufacturing time, accessibility, and patient condition. Therefore, an immediately available, chemotherapy-free treatment strategy that may reduce the cumulative toxicity of conventional cytotoxic chemotherapy is needed.\n\nPolatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that delivers a cytotoxic agent to malignant B cells, and glofitamab is a CD20×CD3 bispecific antibody that activates T cells and induces immune-mediated antitumor activity. The combination of these two agents may provide complementary antitumor effects through direct tumor cell killing and T-cell-mediated immune response.\n\nThis single-arm, open-label, phase 2 study will evaluate the efficacy and safety of polatuzumab vedotin in combination with glofitamab in patients with DLBCL who are primary refractory to or relapse within 12 months after first-line R-CHOP therapy. Approximately 47 participants will be enrolled. The primary endpoint is the complete response rate at the end of treatment, as assessed by the investigator according to Lugano 2014 criteria.",[431],[439,567,568,569,570,571,572],"Relapsed or refractory DLBCL","Polatuzumab vedotin","Glofitamab","Phase 2","Complete response rate","Lugano 2014","2026-07-12",{"date":575,"type":34},"2026-07-14",{"date":577,"type":21},"2026-09-01",{"date":579,"type":21},"2030-08-31",{"name":581,"class":115},"Yonsei University",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":596,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":608},"100610273","phase-1-rituximab-rtx--tafasitamab-in-combination-with-allogeneic-nk-cells-for-treatment-of-relapsedrefractory-rr-b-cell-non-hodgkin-lymphoma-nhl-100610273","NCT07225439","Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma (NHL)","Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of B-cell NHL (indolent and aggressive subtypes) including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)\n* Participants must have measurable disease as defined by Lugano 2014 criteria for NHL or iwCLL 2018 criteria for CLL. For NHL, measurable disease is defined as ≥1 measurable lesion (nodal or extra nodal) ≥1.5 cm in longest diameter by CT or PET\u002FCT. For CLL, iwCLL criteria includes: presence of lymphocytosis (e.g., ALC ≥5 × 10⁹\u002FL), lymphadenopathy ≥1.5 cm, and\u002For disease-related cytopenias (anemia, thrombocytopenia).\n* Relapsed and\u002For refractory after two or more lines of systemic therapy, including prior CD19 and\u002For CD20 directed therapies\n* For participants who have received a prior CD19 or CD20 directed therapy, the presence of CD19 and\u002For CD20 expression (by flow cytometry and\u002For immunohistochemistry) must be demonstrated on a post-treatment relapse biopsy\n* ECOG Performance Status \\\u003C\u002F= 2\n* Preserved organ function as defined by: Total bilirubin \\\u003C\u002F= 1.5X upper limit of normal; AST\u002FALT \\\u003C\u002F= 2.5 X upper limit of normal; Calculated creatinine clearance \\>\u002F= 30mL\u002Fmin estimated by Cockcroft Gualt formula; cardiac ejection fraction \\>\u002F= 45% and no more than mild\u002Ftrace pericardial effusion on a recent echocardiogram; and adequate pulmonary function with oxygen saturation \\>\u002F= 92% on room air.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Second active malignancy (other than non-melanoma skin cancer or carcinoma in situ e.g. cervix, bladder, breast) that would confound interpretation of toxicity assessment or limit survival to prevent evaluation of therapy per discretion of principal investigator. Malignancies treated curatively or with hormonal therapy could be included after discussion with the principal investigator\n* Less than 28 days elapsed between prior treatment with investigational agent(s) and study enrollment\n* New York Heart Association class III-IV congestive heart failure\n* Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration\n* Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness, except well controlled HIV with viral load \\\u003C200 copies\u002FmL on antiretroviral therapy\n* Pregnant or breastfeeding women are excluded from this study because therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants' secondary to treatment of the mother with NK cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Morphologic and\u002For cytogenetic features consistent with diagnosis of myelodysplastic syndrome on the most recent bone marrow biopsy prior to initiation of therapy\n* Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded)\n* Participants with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease\n* Active central nervous system or leptomeningeal involvement by lymphoma. Participants with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurological and other adverse events. Participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast enhanced MRI imaging for at least 90 days prior to registration\n* History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids \\[i.e. maximum of 15mg prednisone equivalent\\] within the last 6 months",{"count":590,"type":21},15,[74],"This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.\n\nNK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death).\n\nParticipants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.",[344,594,85,342,595,79,82,83,78,84],"B-cell Non Hodgkin Lymphoma","Primary Mediastinal Large B Cell Lymphoma",[597,598],"NK cells","Natural Killer cells","2026-07-06",{"date":601,"type":34},"2026-07-08",{"date":603,"type":21},"2026-09",{"date":605,"type":21},"2027-12",{"name":607,"class":115},"Paolo Caimi, MD",2,{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":616,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":619,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":116},"100535235","phase-1-mosunetuzumab-with-chemotherapy-for-the-treatment-of-patients-with-untreated-c-myc-rearrangement-positive-high-grade-b-cell-lymphoma-or-diffuse-large-b-cell-lymphoma-100535235","NCT06249191","Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma","A Phase Ib\u002FII Study Evaluating the Safety and Efficacy of DA EPOCH in Combination With Mosuntuzumab (EPICSUN) in Previously Untreated C-Myc Rearrangement Positive High-Grade B Cell Lymphomas Including Myc Rearranged Diffuse Large B Cell Lymphoma and High Grade B Cell Lymphoma","Inclusion Criteria:\n\n* For both phases of the study, participant must be 18-75 years of age and have previously untreated high-grade B cell lymphoma (HGBCL) or diffuse large B cell lymphoma (DLBCL), including transformed DLBCL per the World Health Organization (WHO) 2022 classification, and with documented c-Myc rearrangement on fluorescence in situ hybridization (FISH) testing. Eligible types of c-Myc rearrangements will be performed by FISH testing and may include any single MYC rearrangement (single-hit lymphoma \\[SHL\\]), Double hit (DHL) lymphoma or and triple hit (THL) lymphoma defined by translocations of MYC and BCL2 (DHL) and BCL6 (THL)\n* Pathology must be verified and confirmed by university pathologists at the enrolling institution and centrally (OHSU) for any biopsies read outside of either institution\n* Stage II or higher and International Prognostic Index (IPI) score of 2-5\n* Able to comply with the study protocol and procedures, in the investigator's judgment\n* At least one bi-dimensionally measurable nodal lesion, defined as ≥ 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as ≥ 1.0 cm in its longest diameter (patients with measurable disease prior to the pre-phase who have disappearance of measurable disease at initiation of study therapy cycle 1 day 1 \\[C1D1\\] are eligible)\n* Confirmed availability of archival or freshly collected tumor tissue before study enrollment\n* Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2\n* Left ventricular ejection fraction (LVEF) defined by multiple-gated acquisition (MUGA) scan or echocardiogram (ECHO) within the institutional limits of normal\n* Absolute neutrophil count (ANC) ≥ 1.0 ×10\\^9\u002FL unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement, or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) without transfusion\n* Platelet count ≥ 75 ×10\\^9\u002FL (unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement, or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) without transfusion\n* Serum creatinine ≤ upper limit of normal (ULN); or estimated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft Gault method or other institutional standard methods, e.g. based on nuclear medicine renal scan\n* For persons of childbearing potential (PCBP), an agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C 1% per year, and confirmed agreement to refrain from donating eggs, during the treatment period and for at least 3 months after the last dose of mosunetuzumab, and 3 months after the last dose of tocilizumab (if applicable), whichever is longer\n* For participants who can produce sperm and create pregnancy: confirmed agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n* Pregnant or breast \u002Fchestfeeding\n* Prior treatment for DLBCL. Exceptions:\n\n  * Course of bendamustine plus rituximab (BR) treatment \\> 3 years prior for follicular lymphoma, or any history of rituximab treatment\n  * As a pre-phase therapy, the following are allowed:\n\n    * Prednisone of ≤ 100 mg for up to a total of 14 days. Prednisone or equivalent corticosteroid must be discontinued by the time of treatment start. These days do NOT have to be consecutive (i.e., can include multiple courses as long as ≤ 14 days)\n    * One cycle of RCHOP (can be dose reduced) or DA R EPOCH or BR or single agent rituximab\n    * Radiation to up to 3 disease sites\n    * For chemotherapy and radiation, a washout of 3 weeks is required (exception: for mediastinal\u002Fpericardial radiation, the washout is 4 weeks)\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n* Contraindication to receive full dose of any of the individual components of EPOCH\n* Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)\n* Known or suspected chronic active Epstein Barr virus (CAEBV) infection\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology)\n\n  \\* Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These Participants must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated\n* Acute or chronic hepatitis C virus (HCV) infection. Participants positive for HCV by antibody testing, but negative for HCV by polymerase chain reaction (PCR) are eligible\n* HIV seropositivity\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Prior solid organ transplantation\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Exceptions:\n\n  * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement may be eligible.\n  * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Participants with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible after review and approval by the primary investigator (PI)\n* Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of pre-phase treatment with prednisone up to 100 mg daily for 7 days (or equivalent corticosteroid dose) prior to cycle 1 day 1 (C1D1). Exceptions:\n\n  * The use of inhaled corticosteroids is permitted.\n  * The use of mineralocorticoids for management of orthostatic hypotension is permitted.\n  * The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted\n* Known active central nervous system (CNS) involvement of lymphoma\n* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease. Exceptions:\n\n  * Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed.\n  * Participants with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed in the expansion cohorts only\n* Prior radiotherapy to the mediastinal \u002F pericardial region within 4 weeks\n* Prior pre-phase chemotherapy and radiation, within 3 weeks is required (Exception noted for mediastinal\u002Fpericardial radiation)\n* Malignancy treated with curative intent unless in documented remission without treatment for 2 years prior to enrollment, or other malignancy that could affect compliance with the protocol or interpretation of results. Exception: Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible. Adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer is permitted\n* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the Participant, including renal disease that would preclude chemotherapy administration or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Significant cardiovascular disease, defined as\n\n  * New York Heart Association \\[NYHA\\] Class III or IV cardiac disease,\n  * Congestive heart failure,\n  * Myocardial infarction within the previous 6 months,\n  * Unstable arrhythmias, or\n  * Unstable angina\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 10 days before C1D1\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 2.5 x ULN\n* Total bilirubin ≥ 1.5 x ULN\n* International normalization ratio (INR) \\> 1.5 x ULN in the absence of therapeutic anticoagulation\n* Partial prothrombin time (PTT) or adjusted partial prothrombin time (aPTT) \\> 1.5 x ULN in the absence of a lupus anticoagulant\n* Herbal therapies intended as treatment of lymphoma\n* Medicinal or recreational cannabis products are not permitted while receiving the study intervention.","75 Years",{"count":618,"type":21},40,[74,53],"This phase Ib\u002FII clinical trial tests the safety, side effects, and effectiveness of mosunetuzumab with chemotherapy for the treatment of patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as mosunetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone work in different ways to stop the growth of cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mosunetuzumab with chemotherapy may be safe, tolerable and\u002For effective in treating patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma.",[27,542],"2026-07-02",{"date":624,"type":34},"2026-07-07",{"date":626,"type":34},"2024-06-13",{"date":628,"type":21},"2027-04-01",{"name":630,"class":115},"OHSU Knight Cancer Institute",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":315,"phases":4,"briefSummary":638,"conditions":639,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":608},"100324252","evaluation-of-human-immune-responses-vaccination-in-patients-with-lymphoma-100324252","NCT03501576","Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma","Inclusion Criteria:\n\n* Subjects with a diagnosis of lymphoma falling into the following categories:\n\n  * B-NHL who have received 1 cycle of chemotherapy\n  * B-NHL in complete remission and within 12 months after completion of chemotherapy\n  * Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receiving ibrutinib for at least 1 month\n  * B-NHL in complete remission for over 12 months\n  * Aggressive peripheral T-cell lymphoma (PTCL) who have received 1 cycle of chemotherapy\n* Subject capable of providing written or electronic informed consent prior to initiation of any study procedures; subjects able to understand and comply with planned study procedures and be available for all study visits.\n\n  * Screening labs must be within the following ranges or considered to be not clinically significant by the investigator:\n\nHematology:\n\n* Hemoglobin: 7.0-16.1 gm\u002FdL\n* Platelet count: 10-600\u002FµL\n* Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season \\*- Platelet count: 10-600\u002FuL\n\n  * For cohort 1: Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season.\n  * For cohort 3: Subjects must have previously received at least 1 dose of SARS-CoV2 vaccine. Patients who have not receive a prior SARS-CoV2 vaccine will be eligible to enroll in cohort.\n\nExclusion Criteria:\n\n* Known infection with human immunodeficiency virus (HIV). This information will be obtained verbally from the patient\n* Have any medical disease or condition that, in the opinion of the site principal investigator is a contraindication to study participation; this includes any chronic medical condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject?s successful completion of this study\n* Have an acute illness, as determined by the site principal investigator within 72 hours prior to study vaccination; an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol and was not due to an influenza infection\n* Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months\n* Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine\n* Have a history of Guillain-Barre syndrome (GBS)\n* Subjects who had or are suspected to have had an influenza infection in the current influenza season\n* Subjects who, at screening, have abnormal vital signs and\u002For physical exam, including a temperature ≥ 38.0 C, systolic blood pressure ≤ 90 or \\> 180 mmHg, pulse ≤ 60 or \\> 130 beats per minute, new rash, signs of infection\n* Subjects who have already received the seasonal influenza vaccine in the current influenza vaccination season\n* Subjects enrolled in hospice or whose life expectancy is less than 6 months",{"count":393,"type":21},"This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma. Evaluating immune response may increase the understanding of how the immune system changes when patients receive treatment for lymphomas by looking at the antibody levels and the level of the different cells that make up the immune system over time compared to those without lymphoma.",[82,27,79,84,640],"Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma","2026-07-01",{"date":599,"type":34},{"date":644,"type":34},"2018-04-06",{"date":646,"type":21},"2028-05-26",{"name":648,"class":115},"Emory University",{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":656,"targetDuration":658,"studyType":315,"phases":4,"briefSummary":659,"conditions":660,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":668},"100512627","a-study-to-evaluate-the-effectiveness-and-safety-of-polatuzumab-in-real-world-clinical-practice-among-adult-chinese-participants-with-diffuse-large-b-cell-lymphoma-100512627","NCT05954910","A Study to Evaluate the Effectiveness and Safety of Polatuzumab in Real World Clinical Practice Among Adult Chinese Participants With Diffuse Large B-Cell Lymphoma","The Effectiveness and Safety of Polatuzumab in Real-World Clinical Practice Among Chinese Adult Patients With Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Registry Study","Inclusion Criteria:\n\n* Be diagnosed as DLBCL\n* Cohort 1: diagnosed as unfit\u002Ffrail DLBCL. The unfit\u002Ffrail is defined as aged 80 years or older, or younger than 80 years but with comorbidity and not tolerant to the standardized dose of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy according to investigator's judgment\n* Cohort 2: diagnosis as DLBCL but could not be classified into unfit\u002Ffrail\n* Cohort 3: relapse or refractory to previous treatment\n\nExclusion Criteria:\n\n* Participant who currently participates in or with plan to participate in any interventional clinical trial\n* Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.",{"count":657,"type":21},1000,"3 Years","The purpose of this study is to assess the progression free survival (PFS) in the real-world settings of polatuzumab among Chinese diffuse large B cell lymphoma (DLBCL) participants.",[27],"2026-06-30",{"date":641,"type":34},{"date":664,"type":34},"2023-08-25",{"date":666,"type":21},"2027-05-31",{"name":325,"class":41},29,{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":4,"eligibilityCriteria":675,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":676,"targetDuration":4,"studyType":22,"phases":678,"briefSummary":679,"conditions":680,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":687,"locationsCount":608},"100587533","phase-3-a-phase-3-clinical-study-of-shr-a1912-combined-with-r-gemox-versus-r-gemox-in-diffuse-large-b-cell-lymphoma-100587533","NCT06929624","A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma","A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).\n2. Have received ≥1 line of systemic antitumor therapy.\n3. At least one bi-dimensionally measurable lesion.\n4. Expected survival of at least 3 months.\n5. Age ≥18 years old and under 80 years old.\n6. The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Central nervous system lymphoma involvement.\n2. Primary mediastinal (thymus) large B-cell lymphoma.\n3. Patients who have only one prior line therapy and are candidates for stem cell transplantation.\n4. A history of immunodeficiency.\n5. A history of severe cardiovascular disease.\n6. A history of other malignancies within 5 years prior to administration of the first dose.",{"count":677,"type":21},280,[24],"This is a multicenter, randomized, open-label, phase 3 clinical study to evaluate the efficacy of SHR-A1912 combined with R-GemOx in relapsed refractory diffuse large B-cell lymphoma.",[431],"2026-06-29",{"date":641,"type":34},{"date":684,"type":34},"2025-04-24",{"date":686,"type":21},"2028-01",{"name":688,"class":41},"Suzhou Suncadia Biopharmaceuticals Co., Ltd."]