[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-hodgkin-lymphoma":217},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,108,0,25,[9,58,82,110,139,175,199,231,258,291,319,350,383,407,438,464,495,533,572,604,629,654,679,714,745],{"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":26,"conditions":27,"keywords":37,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100461905","phase-1-treatment-of-chinese-participants-with-b-cell-malignancies-with-bgb-16673-a-bruton-tyrosine-kinase-targeted-protein-degrader-100461905",false,"NCT05294731","Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader","A Phase 1\u002F2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies","Key Inclusion Criteria\n\n1. Provision of signed and dated written informed consent prior to any study\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria\n4. Phase 1: Confirmed diagnosis of R\u002FR Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL\u002FSLL\n5. Phase 2: Confirmed diagnosis of MCL, or CLL\u002FSLL\n6. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug\n\nKey Exclusion Criteria\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer\n2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment\n3. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.\n4. Current or history of central nervous involvement\n5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply","ALL","18 Years",{"count":20,"type":21},146,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts",[28,29,30,31,32,33,34,35,36],"B-cell Malignancy","Non-Hodgkin Lymphoma","Mantle Cell Lymphoma","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Waldenström Macroglobulinemia","Marginal Zone Lymphoma","Follicular Lymphoma","DLBCL Unclassifiable","Richter's Transformation",[28,38,39,40,36,41,42,43,44],"MZL","FL","DLBCL","CDAC","BTK","degrader","BGB-16673","RECRUITING","2026-08-20",{"date":48,"type":49},"2026-08-21","ACTUAL",{"date":51,"type":49},"2022-05-06",{"date":53,"type":21},"2029-01-31",{"name":55,"class":56},"BeiGene","INDUSTRY",29,{"id":59,"slug":60,"hasResults":12,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"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":67,"type":21},645,[24,25],"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)",[28,33,34,29,32,71,72,30,73],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Diffuse Large B Cell Lymphoma",{"date":48,"type":49},{"date":76,"type":49},"2021-09-13",{"date":78,"type":21},"2029-11",{"name":80,"class":56},"BeOne Medicines",115,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100651625","phase-2-lazarus-it-therapy-for-icans-100651625","NCT07763210","Lazarus: IT Therapy for ICANS","A Phase 2 Trial of Early Enhanced Interventions to Prevent ICANS After CD19 CAR T Therapy in Patients With Non-Hodgkin Lymphoma: Lazarus Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically confirmed non-Hodgkin Lymphoma, including the following types defined by the World Health Organization (2017) or International Consensus Classification (2022):\n\n   * Diffuse large B-cell lymphoma (DLBCL)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Transformed follicular lymphoma (tFL)\n   * Transformed marginal zone lymphoma (tMZL)\n   * High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and\u002For BCL6 rearrangements\n   * Follicular lymphoma\n   * Mantle cell lymphoma\n   * Marginal zone lymphoma\n3. Meets institutional eligibility criteria to receive standard of care CD19 CAR T therapy.\n4. The participant (or legally acceptable representative if applicable) has provided documented informed consent for the trial.\n5. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to allocation.\n\n   Note: 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 anti-HBc, are required for all participants.\n6. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\n   * Participants must have completed curative anti-viral therapy at least 4 weeks prior to allocation.\n   * Hepatitis C screening tests are not required unless: Known history of HCV infection as mandated by local health authority or institutional requirement for CAR T\n7. Participants with HIV are eligible if they meet ALL of the following criteria:\n\n   * The CD4 count is ≥ 350 cells\u002FµL at screening\n   * The HIV viral load is below the detectable level as per locally available testing\n   * Are on a stable ART regimen for at least 4 weeks prior to study entry with good compliance\n   * Note: ART includes drugs, which are NOT strong CYP3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study).\n   * HIV screening tests are not required unless: Known history of HIV infection as mandated by local health authority or institutional requirement for CAR T\n8. Adequate organ function as defined in the following table. Specimens must be collected within 30 days of LD chemo.\n\n   Absolute neutrophil count (ANC) ≥500\u002FµL a Platelets ≥25 000\u002FµL a Hemoglobin ≥7 g\u002FdL a Renal Creatinine OR Measured or calculated b creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN Total bilirubin ≤1.5 ×ULN (except known case of Gilbert's) AST (SGOT) and ALT (SGPT) ≤ 5× ULN Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n9. Participants Assigned Male Sex at Birth\n\n   If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n   * Cytarabine: 1 month\n   * Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR\n   * Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:\n   * Uses a penile\u002Fexternal condom plus nonparticipant of childbearing potential who is not currently pregnant and should also be advised of the benefit for that partner to use an additional method of contraception, as a condom may break or leak.\n\n   Note: Participants capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use penile\u002Fexternal condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate.\n\n   Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n10. Participants Assigned Female Sex at Birth\n\nA participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\nIs not a person of childbearing potential (POCBP) OR\n\nIs a POCBP and: Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 3 during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n• Cytarabine: 1 month- The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed. Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section X. Abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention with IT therapy. Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.\n\nExclusion Criteria:\n\n1. Active HBV\u002FHCV infection. See Inclusion Criteria 7 (HBV) and 8 (HCV) for requirements.\n2. Patients with uncontrolled systemic infection despite appropriate antibiotics or other treatment.\n3. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n4. History of platelet transfusion refractoriness or participant declining transfusion support (i.e. Jehovah's witness).\n5. Participant requiring anti-platelets (aspirin, clopidogrel, ticagrelor) or systemic anticoagulants (coumadin, DOACs) which cannot be safely held at start of LD chemotherapy through Day+28. This is required to avoid delays in rapidly getting IT therapy.\n6. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than high-grade B cell lymphoma. The only exceptions allowed are:\n\n   * Prior or concurrent indolent B cell lymphoma (follicular or marginal zone or lymphoplasmacytic lymphoma) with subsequent high-grade transformation\n   * Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured\n   * Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.\n   * Noninvasive cervical cancer treated within the last 24 months that is considered completely cured\n   * Localized prostate cancer (N0M0):\n\n     1. With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance\n     2. With a Gleason score of 3+4 that has been treated \\>6 months prior to full study screening and considered to have a very low risk of recurrence; or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.\n   * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence\n   * Other malignancy that is considered cured with minimal risk of recurrence.\n   * Known indolent bone marrow disorders such as monoclonal gammopathy of undetermined significance, clonal hematopoiesis of indeterminate potential that in the opinion of the Investigator or Sponsor do not present an increased risk of developing a secondary hematopoietic malignancy.\n7. A POCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for participant to start receiving study medication.\n8. Primary CNS lymphoma, post-transplant lymphoproliferative disorder (PTLD)\n9. Any history of active CNS involvement with lymphoma. Previously treated secondary CNS disease allowed as long as confirmed disease control based on imaging and negative CSF cytology.\n10. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n11. Is currently enrolled on another interventional therapeutic clinical trial which may impact the safety and\u002For efficacy of CAR T therapy.\n12. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.\n13. Has active autoimmune disease on active therapy with systemic biologics and\u002For prednisone ≥ 20mg\u002Fday equivalent. Vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing are allowed to enroll.\n14. Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications.\n\n    Note: Tumor biopsy and placement of central venous access devices are not considered major surgery.\n15. 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.\n16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",{"count":90,"type":21},59,[25],"The goal of this clinical trial is to reduce the duration of ICANS and incidence of G3 or great ICANS in participants who receive axi-cel. The main questions the study aims to answer are: Efficacy of IT therapy to reduce high-grade ICANS in participants who receive axi-cel in NHL compared to historical experience.\n\nResearchers will compare Axi-cel to Brexu-cel see if there will be a reduction in ICANS when compared to historical experience.",[94],"Non-hodgkin Lymphoma",[96,97],"relapsed","refractory","NOT_YET_RECRUITING","2026-08-17",{"date":101,"type":49},"2026-08-19",{"date":103,"type":21},"2026-10-01",{"date":105,"type":21},"2030-10-01",{"name":107,"class":108},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":109},"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":119,"type":21},155,[24,25],"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.",[123,29,124,125],"Lymphoma","Diffuse Large B-Cell Lymphoma","Burkitt Lymphoma",[127,128],"Monoclonal Antibody","Dose-Finding","2026-08-15",{"date":131,"type":49},"2026-08-18",{"date":133,"type":49},"2018-02-09",{"date":135,"type":21},"2027-12-01",{"name":137,"class":138},"National Cancer Institute (NCI)","NIH",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":158,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100652151","phase-2-baff-car-t-cells-lmy-920-for-treatment-of-relapsed-or-refractory-non-hodgkin-lymphoma-and-multiple-myeloma-100652151","NCT07771361","BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma and Multiple Myeloma","Phase 2 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed\u002FRefractory Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)","Inclusion Criteria:\n\n1. Histologically confirmed:\n\n   a. B cell NHL (Including but not limited to diffuse large B cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma) i. Relapsed after 2 or more lines of therapy, or ii. Have disease refractory to prior chemotherapy (defined as progressive disease or stable disease lasting ≤ 6 months, as best response to most recent chemotherapy regimen; or disease progression, or recurrence ≤ 12 months after prior autologous stem cell transplantation (ASCT).\n\n   iii. At least one measurable lesion according to Lugano Revised Response Criteria for Malignant Lymphoma.\n\n   OR b. MM i. Relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.\n\n   ii. Measurable disease per IMWG uniform response criteria\n2. No evidence of CNS lymphoma.\n3. Participant is ≥ 18 years of age.\n4. ECOG Performance status ≤ 2.\n5. \\> 2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis. Patients with mantle cell lymphoma that can only remain stable with continuation of prior BTK inhibitor may continue these agents up to 48 hours prior to apheresis.\n6. Adequate organ function as defined by:\n\n   1. Total bilirubin ≤ 1.5× institutional upper limit of normal (except in patients with Gilbert's syndrome, active hemolysis or disease involvement of the liver.)\n   2. AST (SGOT)\u002FALT ≤ 2.5 × institutional upper limit of normal.\n   3. Calculated creatinine clearance ≥ 30ml\u002Fmin.\n   4. Cardiac ejection fraction of ≥ 50%\n   5. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.\n7. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n8. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the BAFF CAR-T cell infusion.\n9. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures with a failure rate of \\\u003C 1% per year during the treatment period , and agreement to refrain from donating spermfor at least 6 months after the BAFF CAR-T cell infusion.\n\nExclusion Criteria:\n\n1. ASCT within 6 weeks prior to informed consent.\n2. History of allogeneic transplantation.\n3. Active graft-versus-host disease.\n4. Active central nervous system or meningeal involvement by lymphoma or leukemia. Subjects 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 neurologic and other adverse events. Patients 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 enrollment.\n5. Known active additional malignancies which require systemic treatment (non-immediately morbid malignancies receiving only low-toxicity regimens such as hormone suppression for prostate or breast cancer may be allowed at the judgment of the investigator.)\n6. Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.\n7. Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event).\n8. Active infection requiring intravenous systemic treatment.\n9. HIV seropositivity.\n10. Pregnant or breastfeeding women are excluded from this study.\n11. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.\n12. Serologic status reflecting active hepatitis B or C infection. Patients 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 patients will be excluded.)\n13. Patients with history of active and clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n14. Subjects with uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n15. History of autoimmune disease (i.e., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medications (other than low dose steroids) within 2 months.",{"count":147,"type":21},90,[25],"Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against relapsed or refractory B cell non-Hodgkin lymphoma and multiple myeloma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment.\n\nThis Phase 2 study will establish the safety and efficacy profile of LMY-920.",[151,152,153,154,29,155,156,157],"Non-Hodgkin Lymphoma Refractory\u002F Relapsed","Multiple Myeloma Refractory","Multiple Myeloma in Relapse","Non-Hodgkin Lymphoma, B-cell","Non-Hodgkin Lymphoma (NHL)","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Multiple Myeloma in Remission",[159,29,160,161,162,163,123,164,165,166],"Multiple Myeloma","Refractory","Relapsed","CAR-T","B-cell","Neoplasms","Lymphoma, B-Cell","Lymphoma, Non-Hodgkin","2026-08-14",{"date":131,"type":49},{"date":170,"type":21},"2026-12",{"date":172,"type":21},"2031-02",{"name":174,"class":56},"Luminary Therapeutics",{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100612126","a-study-of-voice-as-a-way-to-monitor-for-side-effects-in-people-receiving-car-t-cell-therapy-100612126","NCT07249528","A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy","Voice as a Digital Biomarker of Neurotoxicity in CAR T-Cell Therapy","Inclusion Criteria:\n\n* Documentation of Disease\n\n  o Patients must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.\n* Definition of treatment and ability\n\n  * Scheduled to receive an FDA-approved CAR-T product: Axi-cel, Liso-cel, Tisa-cel, Ide-cel, Cilta-cel, or Brexu-cel.\n  * Ability to comply with twice daily voice recordings or daily neurologic assessments, as determined by the investigator.\n* Age ≥ 18\n* ECOG Performance Status of ≤ 2\n* Required\n\n  * Perform twice daily voice recordings using a smartphone.\n  * Undergo daily neurologic assessments (e.g., ICE score, tremor evaluation).\n  * Smartphone ownership.\n  * Sufficient English proficiency to complete structured voice tasks in the study application.\n* Comorbid Conditions\n\n  * No pre-existing neurological conditions that significantly impair speech, including but not limited to severe dysarthria, expressive aphasia, or neurodegenerative disorders.\n  * No history of significant speech or voice disorders, including laryngeal paralysis, severe dysphonia, or recent vocal cord surgery or radiation to the area.\n  * No pathology affecting the vocal cords that could interfere with voice analysis, such as vocal cord paralysis, chronic laryngitis, vocal cord nodules, polyps, granulomas, or malignancies.\n  * No severe hearing impairment that would interfere with voice assessments\n* Language o Proficiency in spoken English is required, without the need for native-level fluency. This ensures participants can accurately perform structured voice tasks, as the application and underlying acoustic models are currently validated only in English, despite the limitation in generalizability. Participants with language barriers that prevent reliabletask completion or data interpretation will be excluded.",{"count":183,"type":21},20,"OBSERVATIONAL","The purpose of this study is to collect voice recordings and nervous system (neurologic) assessments from people with non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) who are receiving standard treatment with CAR T-cell therapy. Researchers will study whether these voice recordings and assessments are a practical (feasible) way to monitor for immune effector cell-associated neurotoxicity syndrome (ICANS). Feasibility will be measured by tracking how many participants join the study and complete the assessments.",[94,159],[94,159,188,189],"Memorial Sloan Kettering Cancer Center","25-317","2026-08-05",{"date":192,"type":49},"2026-08-06",{"date":194,"type":49},"2026-04-17",{"date":196,"type":21},"2027-12",{"name":188,"class":108},8,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":219,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"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":209,"type":21},32,[24,25],"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.",[213,214,71,72,33,34,30,73,215,125,216,217,218],"B-cell Acute Lymphoblastic Leukemia","Large B-cell Lymphoma","High-grade B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[220,221,123],"CD19-positive","Leukemia","2026-08-04",{"date":192,"type":49},{"date":225,"type":49},"2025-05-30",{"date":227,"type":21},"2031-09",{"name":229,"class":56},"Vironexis Biotherapeutics Inc.",11,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":109},"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":240,"type":21},12,[24],"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.",[217,73,34,33,30,125],[162,245,246,247,248,249,250],"Chimeric antigen receptor T-cell therapy","CAR Therapy","Pirtobrutinib","B Cells","BTK inhibitor","Bruton's tyrosine kinase",{"date":192,"type":49},{"date":253,"type":49},"2025-02-06",{"date":255,"type":21},"2030-07",{"name":257,"class":108},"Medical College of Wisconsin",{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":267,"conditions":268,"keywords":276,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":109},"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":266,"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)\").",[29,269,124,270,271,272,273,274,34,275],"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",[29,269,73,271,272,275,273,277,34,278,40,279,270,280,281,39,282],"Follicular Lymphoma grade 3B","NHL","HGBCL","PMBCL","PTCL","ALCL","2026-08-03",{"date":192,"type":49},{"date":286,"type":21},"2026-07-27",{"date":288,"type":21},"2032-04",{"name":290,"class":56},"Natera, Inc.",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":300,"conditions":301,"keywords":307,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":230},"100525005","lentiviral-gene-therapy-zamtocabtagene-autoleucel-ltfu-100525005","NCT06116110","Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU","A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a North American Miltenyi Biomedicine-Sponsored Clinical Study","Inclusion Criteria:\n\n* Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.\n* Provided written informed consent to participate in this study.\n\nExclusion Criteria:\n\n* None",{"count":299,"type":21},150,"This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.",[217,302,303,304,305,306],"Refractory Diffuse Large B Cell Lymphoma (DLBCL)","Relapsed Diffuse Large B Cell Lymphoma","High Grade B-cell Lymphoma","Central Nervous System Lymphoma","Primary Mediastinal B-cell Lymphoma (PMBCL)",[308,309,310,311],"Chimeric antigen receptor","CAR T","CD19","CD20",{"date":190,"type":49},{"date":314,"type":49},"2024-05-15",{"date":316,"type":21},"2041-12-01",{"name":318,"class":56},"Miltenyi Biomedicine GmbH",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":331,"conditions":332,"keywords":338,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":349},"100607438","phase-3-a-study-to-investigate-ronde-cel-versus-investigators-choice-cd19-car-t-cell-therapy-100607438","NCT07188558","A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy","A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19\u002FCD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting","PiNACLE-H2H","Key Inclusion Criteria:\n\n1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy\n2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)\n\n   * Diffuse large B-cell lymphoma (DLBCL)\n   * Transformations of indolent B-cell lymphomas (excluding Richter's transformation)\n   * DLBCL\u002FHigh-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements\n   * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Grade 3B follicular lymphoma\u002Flarge cell follicular lymphoma (FL3B)\n3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy\n4. Measurable disease by presence of \\[18F\\]-fluorodeoxyglucose PET\u002FCT positive lesion during Screening per Lugano Criteria\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria:\n\n1. Patients ineligible to receive CD19 CAR T-cell therapy\n2. Primary CNS lymphoma\n3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (Richter's transformation)\n4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years\n5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment\n6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":328,"type":21},400,[330],"PHASE3","This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19\u002FCD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.",[214,165,333,334,29,151,335,336,337],"Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma (DLBCL)","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed",[123,29,339,310,340,214],"CAR T-Cell Therapy","CD19\u002FCD20","2026-07-31",{"date":222,"type":49},{"date":344,"type":49},"2026-01-12",{"date":346,"type":21},"2032-01",{"name":348,"class":56},"Lyell Immunopharma, Inc.",36,{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":367,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":382},"100488822","phase-3-a-study-to-evaluate-efficacy-safety-and-pk-of-xembifystandard-medical-treatment-smt-compared-to-placebosmt-to-prevent-infections-in-participants-with-hgg-and-recurrent-or-severe-infections-associated-with-b-cell-chronic-lymphocytic-leukemia-multiple-myeloma-and-non-hodgkin-lymphoma-100488822","NCT05645107","A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","EXCELL","Inclusion Criteria:\n\n* Participants ≥18 years of age at screening visit\n* Participants with documented and confirmed diagnosis of any of the below diseases:\n\n  * B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)\n  * MM according to the International Myeloma Working Group criteria (IMWG), R-ISS stage II or, III; or\n  * Histologically confirmed diagnosis of B-Cell NHL, Stage III or above (IV, Progressive\u002Frefractory, or recurrent\u002Frelapsed stage) according to the Lugano Classification.\n* Participants with HGG with IgG levels less than 5 g\u002FL. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein \\[Mspike\\] to reflect the true polyclonal IgG concentration.)\n* Participants with documented history of at least one severe bacterial infection (bacterial or viral) or recurrent bacterial\u002Fviral infections (that is., ≥ 3 infections) within 12 months before the screening visit. Severe bacterial\u002Fviral infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grades).\n\nExclusion Criteria:\n\n* Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 months) before Screening visit.\n* Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the screening visit.\n* Participants with active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and\u002For local\u002Finternational guidelines for the CLL, and defined in local\u002Finternational guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation in the trial is also allowed.\n* Participants with active second malignancies.\n* Participants with known primary immunodeficiency (PI).\n* Participants with a life expectancy less than 1.5 years.\n* Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.\n* Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.\n* Participants have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator's discretion.\n* Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).\n* Participants with severe known kidney disease \\[as defined by estimated glomerular filtration rate \\[eGFR\\] less than (\\&amp;amp;lt;) 30 milliliter (mL)\u002Fmin\u002F1.73 square meter (m2)\\] as determined by the Principal Investigator.\n* Participants that have liver enzyme levels (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], gammaglutamyl transferase \\[GGT\\], or lactate dehydrogenase \\[LDH\\]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory.\n* Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis.\n* Participants currently have a known hyperviscosity syndrome or hypercoagulable states.\n* Participants have a known previous infection or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.\n* Participants with non-controlled arterial hypertension (systolic blood pressure \\[SBP\\] greater than 140 millimeters of mercury (mmHg) and\u002For diastolic blood pressure \\[DBP\\] greater than 90 mmHg), and\u002For a heart rate (HR) greater than100 bpm.\n* Participants with known substance or prescription drug abuse within 12 months before the Screening Visit.\n* Participants have participated in another clinical trial within 30 days prior to screening (observational studies without investigative treatments \\[non-interventional\\] are permitted).",{"count":359,"type":21},386,[330],"The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.",[363,364,365,366,29],"Hypogammaglobulinemia","Bacterial Infections","B-cell Chronic Lymphocytic Leukemia","Multiple Myleoma",[368,369,370,371,372,278],"XEMBIFY","CLL","SMT","Hypogammaglobulinemia (HGG)","MM","2026-07-28",{"date":375,"type":49},"2026-07-29",{"date":377,"type":49},"2022-12-26",{"date":379,"type":21},"2029-08",{"name":381,"class":56},"Grifols Therapeutics LLC",62,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":109},"100649159","phase-1-clinical-study-of-xnw5004-combined-with-chopchoep-in-the-treatment-of-untreated-peripheral-t-cell-lymphoma-100649159","NCT07730515","Clinical Study of XNW5004 Combined With CHOP\u002FCHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma","A Phase Ib\u002FII Clinical Study of XNW5004 Combined With CHOP\u002FCHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma","Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive); both genders are eligible.\n* Pathologically confirmed peripheral T-cell lymphoma (PTCL).\n* No prior systemic anti-PTCL therapy.\n* At least one measurable lesion as the basis for evaluation: nodal lesions with a long diameter \\> 1.5 cm; extranodal lesions with a long diameter \\> 1.0 cm.\n* Life expectancy of at least 12 weeks.\n* ECOG performance status score of 0-1.\n* Vital organ function reserves meet the following requirements:\n* Hematopoietic function:\n* White blood cell count \\>= 3.5 x 10\\^9\u002FL (no G-CSF administration within 1 week before the screening blood test, and no long-acting leukocyte-elevating agent administration within 2 weeks)\n* Platelet count \\>= 75 x 10\\^9\u002FL (no platelet transfusion or TPO receptor agonist administration within 1 week before the screening blood test)\n* Hemoglobin \\>= 80 g\u002FL (no red blood cell transfusion or EPO administration within 1 week before the screening blood test)\n* Hepatic function: serum total bilirubin \\\u003C= 1.5 x ULN (\\\u003C= 3 x ULN for Gilbert's syndrome), and ALT and AST \\\u003C= 2.5 x ULN; for subjects with liver infiltration, ALT\u002FAST \\\u003C= 5 x ULN; for subjects with liver and\u002For bone infiltration, alkaline phosphatase \\\u003C= 5 x ULN\n* Renal function: serum creatinine \\\u003C= 1.5 x ULN or estimated creatinine clearance \\>= 60 mL\u002Fmin according to the Cockcroft-Gault formula\n* Left ventricular ejection fraction (LVEF) \\>= 50%\n* International normalized ratio (INR) \\\u003C= 1.5 x ULN, or prothrombin time (PT) and activated partial thromboplastin time (APTT) \\\u003C= 1.5 x ULN\n* Women of childbearing potential must have a negative serum pregnancy test before entering this study and agree to use effective contraception from the start of the study until at least 6 months after the last dose of the investigational drug. Female subjects who are not capable of childbearing must have been naturally amenorrheic for at least 12 months and be confirmed by a specialist physician as having no reproductive function based on female hormone testing; or have undergone bilateral oophorectomy, hysterectomy, or tubal ligation at least 6 weeks prior to screening. Male subjects must agree to use adequate contraceptive measures from the start of the study until at least 6 months after the last dose of the investigational drug, and must not donate sperm.\n* Provide a signed and dated written informed consent form prior to undergoing study-specific procedures, and be able to comply with clinical visits and study-related procedures.\n\nExclusion Criteria:\n\n* Prior treatment with any anti-tumor therapy, including but not limited to: chemotherapy, immunotherapy, radiotherapy, targeted therapy, anti-tumor traditional Chinese medicine, or anti-tumor investigational drugs.\n* Subjects with known hypersensitivity to the investigational drug or its active ingredients or excipients.\n* Subjects who have undergone major surgery within 4 weeks prior to the first dose of the investigational drug, or who plan to undergo major surgery during the study period (except for procedures such as puncture or lymph node biopsy).\n* Prior or planned allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n* Receipt of steroid hormones for anti-tumor purposes (daily dose \\> 20 mg prednisone or equivalent dose of other glucocorticoids) within 7 days prior to the first dose of the investigational drug; or diseases requiring systemic treatment with steroid hormones (daily dose \\> 10 mg prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the first dose of the investigational drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with a daily dose \\\u003C= 10 mg prednisone or equivalent dose of other glucocorticoids are permitted.\n* Subjects who have taken known moderate or strong CYP3A4 inhibitors\u002Finducers within 14 days prior to the first dose.\n* Receipt of live virus vaccine (including attenuated live vaccine) within 28 days prior to dosing. Inactivated vaccines are permitted.\n* History of psychotropic substance abuse or drug addiction.\n* History of other malignancies within 3 years prior to enrollment that do not meet clinical cure criteria. The following are exceptions: basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and has been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.\n* Mycosis fungoides, Sezary syndrome, and primary cutaneous T-cell lymphoma.\n* Presence of central nervous system involvement.\n* Presence of testicular or breast involvement.\n* Prior or current hemophagocytic syndrome.\n* Prior or current immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, or other primary or secondary hematological diseases that may affect bone marrow function other than the primary malignancy.\n* Prior or current acute myeloid leukemia (AML).\n* Prior or current T-cell lymphoblastic lymphoma (T-LBL) or T-cell lymphoblastic leukemia (T-ALL).\n* History of any myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal laboratory markers associated with MDS or myeloproliferative neoplasm (MPN).\n* Prior or concomitant central nervous system disorders, including but not limited to: epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, etc.\n* Impaired cardiac function or clinically significant cardiac disease, including any of the following:\n* Acute myocardial infarction within 12 months prior to the first dose\n* Unstable angina pectoris\n* Congestive heart failure (New York Heart Association functional class III or IV)\n* Uncorrected serious arrhythmia, hypertension \\>= 150\u002F100 mmHg\n* Prolonged QTc interval (defined as \\> 450 ms for males and \\> 470 ms for females, by Fredericia's formula)\n* Prior history of other major cardiovascular diseases (e.g., valve replacement, coronary artery bypass grafting, etc.)\n* Tumor invasion of surrounding vital organs and blood vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) with risk of bleeding, or risk of tracheoesophageal fistula or esophagopleural fistula.\n* Subjects with clinically symptomatic pleural effusion, ascites, or pericardial effusion that is poorly controlled despite repeated treatment.\n* Active severe systemic infection: a washout period of at least 2 weeks is required after completion of antifungal therapy (whether administered intravenously or orally); a washout period of at least 1 week is required after completion of other intravenous anti-infective therapy; other oral anti-infective therapies must be discontinued before the first dose of the investigational drug.\n* Active tuberculosis under treatment.\n* HIV-positive or syphilis (Anti-TP) positive subjects (subjects with negative syphilis non-specific antibody test results and judged by the investigator to have been cured of syphilis are not excluded).\n* HBsAg positive with HBV-DNA copy number above the lower limit of normal detection, or HBcAb positive with HBV-DNA copy number above the lower limit of normal detection; HCV antibody positive with HCV-RNA copy number above the lower limit of normal detection.\n* Subjects who are unable to swallow, or have active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or a history of gastrectomy or gastric banding that may affect drug absorption. However, gastroesophageal reflux treated with proton pump inhibitors is permitted (if there is no potential for drug interaction).\n* Known hemorrhagic diathesis such as von Willebrand disease or hemophilia.\n* Females who are pregnant or breastfeeding.\n* Subjects who may not be able to complete the study for other reasons or whom the investigator considers should not be enrolled.","75 Years",{"count":392,"type":21},176,[24,25],"In this study, the XNW5004 tablets combined with CHOP\u002FCHOEP will be used for the treatment of newly diagnosed PTCL patients.",[94,396],"Peripheral T-cell Lymphoma",[398,399],"EZH2 inhibitor","XNW5004",{"date":375,"type":49},{"date":402,"type":49},"2025-08-15",{"date":404,"type":21},"2028-09-30",{"name":406,"class":56},"Evopoint Biosciences Inc.",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":414,"sex":17,"minAge":18,"maxAge":390,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":437},"100594521","phase-1-a-vaccine-cmv-mva-triplex-vaccine-for-the-enhancement-of-cmv-specific-immunity-and-the-prevention-of-cmv-viremia-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplant-100594521","NCT07020533","A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant","A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* DONORS: Age: 18 - 75.\n* DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* DONORS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* RECIPIENTS: Documented informed consent of the participant and\u002For legally authorized representative. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* RECIPIENTS: Participant must be willing to comply with study and\u002For follow-up procedures, including willingness to be followed for one year post-HCT.\n* RECIPIENTS: Age: 18 - 75.\n* RECIPIENTS: Planned peripheral blood stem cell (PBSC) or bone marrow (BM) HCT for the treatment of the following hematologic malignancies:\n\n  * Lymphoma (Hodgkin and Non-Hodgkin).\n  * Myelodysplastic syndrome.\n  * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia\u002Flymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography (CT) or CT\u002Fpositron emission tomography(PET) scan without progression is allowed.)\n  * Acute myeloid leukemia in first or second remission.\n  * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase.\n  * Other hematologic malignancies judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\\*\\*.\n\n    * Adult cases of multiple myeloma (MM) are excluded as HCT is not standard of care for MM and is only performed in very advanced cases with an associated high risk of relapse and non-relapse mortality (NRM). Adults with aplastic anemia are excluded because their standard management includes T cell depletion with agents such as antithymocyte globulin (ATG), which is not permissible on this protocol. Patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible).\n* RECIPIENTS: Patients receiving myeloablative (MA) or reduced intensity conditioning (RIC) are allowed.\n* RECIPIENTS: CMV seropositive.\n* RECIPIENTS: Eligible haploidentical donors will have 2-4 mismatches if human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 typing is used; 2-5 mismatches if HLA-A, -B, -C, -DRB1, and -DQB1 typing is used; and 2-6 mismatches if HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 typing is used. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must demonstrate that they are a full haplotype match by being identical at a minimum of one allele (at high resolution deoxyribonucleic acid \\[DNA\\]-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 if 8 allele typing is used; HLA-A, -B, -C, -DRB1, and -DQB1 if 10 allele typing is used; and HLA-A, -B, -C, -DRB1-, DQB1, and -DPB1 is 12 allele typing is used.\n* RECIPIENTS: Planned HCT with minimal to no-T cell depletion of graft.\n* RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.\n* RECIPIENTS: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Estimated creatinine clearance acceptable per institutional guidelines (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  * Note: To be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n\n  * If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air.\n  * Note to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis c virus (HCV)\\*, active hepatitis b virus (HBV) (surface antigen negative) and syphilis (RPR) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease.\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n* RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements.\n\n  * Note Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and up to 90 days post-HCT.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).\n* DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.\n* DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.\n* DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.\n* DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.\n* DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.\n* DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.\n* DONORS: Females only: Pregnant or breastfeeding.\n* DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* DONORS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).\n* RECIPIENTS: Any prior investigational CMV vaccine.\n* RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months.\n* RECIPIENTS: Live attenuated vaccines (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Allergy treatment with antigen injections (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD34+ selection) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)\u002Fvalganciclovir (VAL), foscarnet (FOS), cidofovir, CMX-001, maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment EXCEPT letermovir prophylaxis (prior to day 100) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Disease-based radiation therapy (not total body irradiation) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other investigational product(s) - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years.\n* RECIPIENTS: Patients considered by PI\u002Fconsenting physicians to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and\u002For undergoing 2nd HCT).\n* RECIPIENTS: Poor risk disease\u002Fdisease status including: Chronic myelogenous leukemia (CML) in blast crisis, acute myeloid leukemia (AML)\u002Facute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia.\n* RECIPIENTS: Females only: Pregnant or breastfeeding.\n* RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* RECIPIENTS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",true,{"count":416,"type":21},46,[24],"This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and\u002For effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.",[420,421,422,71,423,424,425,426,427,428,429,29],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Myelodysplastic Syndrome","Myelofibrosis","Myeloproliferative Neoplasm",{"date":373,"type":49},{"date":432,"type":49},"2026-05-08",{"date":434,"type":21},"2029-05-30",{"name":436,"class":108},"City of Hope Medical Center",3,{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":445,"maxAge":446,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":109},"100517121","phase-2-cord-blood-transplant-cyclophosphamide-fludarabine-and-total-body-irradiation-in-treating-patients-with-high-risk-hematologic-diseases-100517121","NCT06013423","Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics","Inclusion Criteria:\n\n* Patients aged 6 months to =\\\u003C 65 years at time of consent.\n* Acute myelogenous leukemia (AML):\n\n  * Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have \\\u003C 5% marrow blasts at the time of transplant.\n  * Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible.\n* Acute lymphoblastic leukemia (ALL):\n\n  * Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n    * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n    * Failure to achieve MRD- complete remission after induction therapy.\n    * Persistence or recurrence of minimal residual disease on therapy.\n    * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n    * Other high-risk features not defined above.\n  * Complete second remission (CR2) or greater (CR2+).\n\n    * Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Chronic Myeloid Leukemia (CML): Excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy.\n* Myelodysplastic syndromes (MDS) and myeloproliferative disorders (MPD) other than myelofibrosis:\n\n  * MDS\u002FMPD overlap syndromes without myelofibrosis.\n  * MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and absolute neutrophil count (ANC) \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n* Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\n  * Eligible patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histology) in CR by PET\u002FCT imaging.\n  * Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n* Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n* Only for adult patients, to prevent graft rejection, patients who received only non-lymphodepleting agents for their malignancy (hypomethylating agents, venetoclax, hydroxyurea, TKIs etc.), or patients who received lymphodepleting chemotherapy \\> 3 months prior to scheduled admission, may receive fludarabine 25 mg\u002Fm\\^2 daily x 3 days for lymphodepletion 14-42 days (aiming for 2-4 weeks) at the discretion of the principal investigator (PI).\n* For patients \\> 18 years old, Karnofsky score ≥ 70%. For patients =\\\u003C 18 years old, Lansky score ≥ 50%.\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* Alanine transaminase (ALT) \\\u003C 3 x upper limit of normal (ULN).\n* For patients \\> 18 years old, pulmonary function (spirometry and corrected diffusing capacity for carbon monoxide \\[DLCO\\]) \\> 60% predicted. For patients =\\\u003C 18 years old, or any patient unable to perform pulmonary function tests, O2 saturation \\> 92% on room air.\n* Left ventricular ejection fraction \\> 50%.\n* Albumin \\> 3.0 g\u002FdL.\n* For patients \\> 18 years old, Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) =\\\u003C 5.\n* UCB units will be selected according to current umbilical cord blood graft selection algorithm. One or two UCB units may be used to achieve the required cell dose.\n* The UCB graft is matched at 4-6 HLA-A, B, DRB1 antigens with the recipient. This may include 0-2 antigen mismatches at the A or B or DRB1 loci. Unit selection based on cryopreserved nucleated cell dose and HLA-A, B, DRB1 using intermediate resolution A, B antigen and DRB1 allele typing.\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients persistent with central nervous system (CNS) involvement in cerebrospinal fluid (CSF) or CNS imaging at time of screening0\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy total body irradiation (TBI) in the opinion of radiation oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Inadequate performance status\u002F organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.","6 Months","65 Years",{"count":448,"type":21},54,[25],"This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.",[452,421,422,453,424,218,427,429,29,454],"Acute Leukemia of Ambiguous Lineage","Blastic Plasmacytoid Dendritic Cell Neoplasm","Chronic Myeloid Leukemia, BCR-ABL1 Positive","2026-07-20",{"date":457,"type":49},"2026-07-22",{"date":459,"type":49},"2024-07-23",{"date":461,"type":21},"2032-10-31",{"name":463,"class":108},"Fred Hutchinson Cancer Center",{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":472,"maxAge":390,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":481,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":494},"100529662","phase-1-constitutive-il7r-c7r-modified-banked-allogeneic-cd30car-ebvsts-for-cd30-positive-lymphomas-100529662","NCT06176690","Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas","Constitutive IL7R (C7R) Modified Banked Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas","CABAL2","Inclusion Criteria:\n\n1. Diagnosis and clinical course falling into one of the following categories:\n\n   1. Hodgkin lymphoma\n   2. CD30+ aggressive B-cell lymphoma\n   3. ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma\n   4. ALK-positive anaplastic T cell lymphoma\n2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.\n3. Age 12 to 75.\n4. Bilirubin less than or equal to 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin less than or equal to 3 times the upper limit of normal).\n5. AST less than 3 times the upper limit of normal.\n6. Estimated GFR \\> 70 mL\u002Fmin.\n7. Pulse oximetry of \\> 90% on room air\n8. Karnofsky or Lansky score of \\> 60%.\n9. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.\n10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.\n11. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.\n\nExclusion Criteria:\n\n1. Received an investigational cell therapy or vaccine within the past 6 weeks.\n2. Received an investigational small molecule drug within the past 2 weeks.\n3. Received anti-CD30 antibody-based therapy within the previous 4 weeks.\n4. History of hypersensitivity reactions to murine protein-containing products.\n5. Pregnant or lactating.\n6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).\n7. Current use of systemic corticosteroids at a dose equivalent to or higher than 10 mg\u002Fday of prednisone.\n8. Active significant, uncontrolled bacterial, viral or fungal infection.\n9. Symptomatic cardiac disease (NYHA Class III or IV disease).","12 Years",{"count":147,"type":21},[24],"This study involves patients with diffuse large B cell lymphoma (DLBCL), natural killer\u002FT-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment.\n\nPrevious research combined antibodies and T cells to treat cancer. Antibodies bind to foreign substances, and T cells are infection-fighting white blood cells that can kill tumor cells. Both approaches have shown promise but have not been sufficient to cure most patients. In prior studies, an antibody targeting CD30, a protein found on some T cells and cancer cells, was joined to T cells through gene transfer to create CD30.CAR T cells.\n\nAnother study showed encouraging responses using CD30.CAR T cells made from a patient's own blood and returned to the same patient (autologous cells). In an ongoing study, patients have been treated with CD30.CAR T cells derived from healthy donors (allogeneic cells), allowing use of banked cells without individualized manufacturing. This approach has shown promising clinical activity with no safety concerns to date.\n\nIn this study, investigators are evaluating CD30.CAR-EBVST cells modified with an additional molecule called C7R, which has been shown in laboratory studies to enhance anti-cancer effects. The study aims to assess the safety and effectiveness of these allogeneic, banked C7R-modified CD30.CAR-EBVST cells and determine whether they may help treat lymphoma.\n\nAs an added safety measure, the modified T cells include a marker called iC9. If significant side effects occur, patients may receive rimiducid, which can eliminate the infused T cells. Rimiducid is not yet FDA approved but has been tested in patients without significant side effects.",[477,478,479,396,480,29,425],"CD30-Positive Diffuse Large B-Cell Lymphoma","Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-negative",[482,483,484,485],"CD30-Positive Lymphoma","Hodgkin lymphoma","non-Hodgkin lymphoma","CD30 CAR","2026-07-17",{"date":455,"type":49},{"date":489,"type":49},"2025-10-27",{"date":491,"type":21},"2043-06-27",{"name":493,"class":108},"Baylor College of Medicine",2,{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":472,"maxAge":390,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":506,"conditions":507,"keywords":516,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100647682","study-to-characterize-mismatched-to-fully-hla-matched-ossium-hpc-marrow-and-living-donor-transplantation-in-patients-with-hematologic-malignancies-100647682","NCT07710781","Study to Characterize Mismatched to Fully HLA-Matched Ossium HPC, Marrow and Living Donor Transplantation in Patients With Hematologic Malignancies","A Multicenter, Open Label Study to Evaluate the Efficacy, Tolerability, and Safety of Partially to Fully HLA-Matched Allogeneic Cryopreserved Deceased-Donor Bone Marrow Transplantation and Living Donor Transplantation in Patients With Hematologic Malignancies","Inclusion Criteria:\n\n1. Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements.\n2. Male or female, aged ≥12 and ≤65 years for patients receiving MAC aged ≥12 and ≤75 years for patients receiving RIC. Patients between 75 and 80 years on RIC regimen can be enrolled with prior sponsor approval\n3. Patient must require first allogeneic HCT per the discretion of the treating physician\n4. BMI \\\u003C=50 (BMI of 45.1 to 50 maybe allowed after sponsor approval)\n5. For treatment from Ossium product only- no suitable donor available after 3 weeks of search\n6. Patient must be high-resolution:\n\n   1. HLA partially or fully matched (4-8\u002F8 allele matched at HLA-A, -B, -C, DRB1) to an available Ossium HPC, Marrow product for experimental arm\n   2. HLA fully matched (8\u002F8 allele matched at HLA-A, -B, -C, DRB1) to an unrelated available PBSC donor for observational standard of care arm\n   3. HLA partially matched (4-7\u002F8 allele matched at HLA-A, -B, -C, DRB1) to an available PBSC donor for observational standard of care arm\n   4. HLA haploidentical matched (4\u002F8 allele matched at HLA-A, -B, -C, DRB1) to available PBSC donor for observational standard of care arm\n   5. HLA partially matched (4-8\u002F8 allele matched at HLA-A, -B, -C, DRB1) to an available living bone marrow donor for optional observational standard of care arm\n7. Stated willingness to comply with all study procedures and availability for the duration of the study\n8. Patient with malignant hematologic disease including:\n\n   1. Diagnosed with acute leukemia \\[acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)\\], , in the first remission or beyond with ≤5% marrow blasts and no circulating blasts or extra-medullary disease documented by bone marrow assessment within 42 days prior to anticipated start of conditioning or\n   2. MDS without Grade 3 fibrosis (Patients with Grade 1 and Grade 2 fibrosis can be enrolled with prior sponsor approval)\n   3. Chronic Lymphocytic Leukemia (CLL) eligible for allogeneic transplant or\n   4. Chronic Myeloid leukemia (CML) eligible for allogeneic transplant\n   5. Chemosensitive lymphomas in the first remission or beyond documented by PET\u002FCT imaging and bone marrow assessment within 42 days prior to anticipated start of conditioning\n   6. Other rare hematological malignancy indications eligible for allogenic transplant will require prior sponsor review and approval\n   7. Absence of active CNS disease due to underlying hematological disease\n9. Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)\n10. HCT comorbidity index (HCT-CI) ≤5\n11. Adequate organ function defined as:\n\n    1. Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC)\n    2. Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected (dinakara correction) for hemoglobin.\n    3. Hepatic: total bilirubin ≤2.0 mg\u002FdL (except Gilbert syndrome ), and ALT, AST, and ALP \\\u003C3 x upper limit normal (ULN), unless ALT, AST, and\u002For ALP are disease related\n    4. Renal: CrCl\\> 45 mL\u002Fmin\u002F1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula)) or Cystatin-C test.\n\nExclusion Criteria:\n\n1. Autologous transplant within 6 months\n2. Prior allogeneic HCT\n3. Myeloproliferative disorders or MDS with grade 3 and higher fibrosis are excluded\n4. HTLV-ATLL positive patients are excluded\n5. Currently Pregnant or Currently lactating parent\n6. Participation with an investigational trial within 3 months of planned transplant (Note: participation in survey studies or standard of care studies maybe allowed after sponsors approval or are part of long term follow up for an interventional trial)\n7. Recipient of allogeneic CART-T therapy\n8. Recipient of checkpoint inhibitor in last 3 months\n9. Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings\n10. Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation\n11. Presence of donor-specific antibodies. Recipient has positive anti-donor HLA antibodies against a mismatched HLA in the selected donor determined by either:\n\n    1. positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing) or\n    2. presence of donor specific HLA antibodies (DSA) to any mismatched HAS allele\u002Fantigen at any of the following loci (HLA-A, -B, -C, -DRB1, -DPA1, -DPB1) with median fluoresce intensity (MFI) \\>3000 by Luminex single antigen bead based solid phase immunoassay tested prior to SSA request and repeated if transplant is \\>30 days from prior HLA antibody testing or if patient receives additional blood products\u002Ftransfusion prior to transplant\n    3. Patients with donor specific HLA antibodies (DSA) to donor that is reduced post treatment of de-sensitization for DSA",{"count":503,"type":21},300,[505],"NA","Prospective, multi-center open label study of HLA-partially to fully matched allogeneic cryopreserved deceased donor bone marrow transplantation and living donor transplantation for patients with hematologic malignancies.",[508,509,421,422,510,511,512,513,514,217,425,515],"Hematologic Malignancy","Acute Leukemia","Acute Biphenotypic Leukemia","Acute Undifferentiated Leukemia","CLL (Chronic Lymphocytic Leukemia)","Chronic Myeloid Leukemia","MDS (Myelodysplastic Syndrome)","Cutaneous T Cell Lymphomas (CTCL)",[221,517,17,518,519,520,521,522,123,523,369,524],"Hematologic Diseases","AML","ABL","AUL","Bone Marrow Transplant","Stem cell Transplant","MDS","CML","2026-07-16",{"date":455,"type":49},{"date":528,"type":21},"2026-12-01",{"date":530,"type":21},"2031-03-31",{"name":532,"class":56},"Ossium Health, Inc.",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":570,"locationsCount":109},"100560657","phase-2-repurposing-riluzole-for-cancer-related-cognitive-impairment-a-pilot-trial-100560657","NCT06580002","Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial","Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial","Inclusion Criteria:\n\n1. Cohort-specific inclusion for male and female patients.\n\n   a. Cohort A (no prior cranial radiation) i. Diagnosed with one of the following:\n   * Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and\u002For other breast cancer interventions.\n   * Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years.\n   * Non-breast cancer patients exposed to other anticancer therapies within the past 3 years.\n\n     b. Cohort B (prior cranial radiation)\n   * Previously received radiotherapy or radiosurgery to the brain for benign, malignant, or metastatic tumors.\n   * Life expectancy \\> 6 months\n2. Washout from investigational and conventional interventions is up to the discretion of the investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study.\n3. ≥18 years of age\n4. Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or cancer treatment.\n5. Able to provide informed consent.\n6. Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires.\n7. Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes.\n\n   * Note: Patients who have visual impairment or have degenerative conditions (e.g. Parkinsons's disease, etc.) can participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.\n\nExclusion Criteria:\n\n1. Cohort-specific exclusion for male and female patients:\n\n   1. Cohort A (no prior cranial radiation)\n\n      * History of or current presence of primary brain tumors or brain metastases.\n   2. Cohort B (prior cranial radiation)\n\n      * Diagnosed with high grade glioma.\n2. Unwilling to undergo neuropsychological assessments necessary for the study.\n3. Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Persons of child-bearing potential (POCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy.\n\n   a. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n4. History of suspected hypersensitivity to riluzole or to any of its excipients.\n5. Patients taking or planned to take medications\u002Fsubstances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole.\n6. Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN)\n7. Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.",{"count":541,"type":21},75,[25],"This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels in cancer survivors (recently completing prior treatment regimens) or patients who have received whole brain radiation for benign or malignant tumors with cancer related cognitive impairment.",[545,546,547,548,549,550,551,552,553,554,555,221,556,557,558,559,94,425,560,561,562,563],"Breast Cancer","Sarcoma","Gastric Cancer","Lung Cancer","Head and Neck Cancer","Colorectal Cancer","Ovarian Cancer","Liver Cancer","Genitourinary Cancer","Gynecologic Cancer","Urinary Bladder Cancer","Lymphoid Leukemia","Myeloma Multiple","Prostate Cancer","Pancreas Cancer","Brain Cancer","Melanoma","Mycosis Fungoides","Kidney Cancer","2026-07-11",{"date":566,"type":49},"2026-07-14",{"date":568,"type":49},"2024-12-02",{"date":196,"type":21},{"name":571,"class":108},"University of California, Irvine",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":446,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":586,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":109},"100612531","phase-1-prophylactic-and-therapeutic-dli-x-for-leukemia-relapse-after-hct-100612531","NCT07254793","Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT","A Feasibility\u002FPilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent or Treat Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation","DLI Recipient Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 0-65 years\n* Diagnosis of acute leukemia (lymphoid, myeloid or undifferentiated) myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) or non-Hodgkin's lymphoma (NHL)\n* Undergoing myeloablative or reduced intensity matched sibling donor (MSD) HCT or haploidentical HCT\n* Have a locally available healthy matched or haploidentical (≥5\u002F10 HLA antigen matched) related donor between 12 and 50 years of age, consented and able to perform the exercise sessions. (see donor inclusion criteria)\n* The familial donors will first complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Donor Inclusion Criteria:\n\n* Matched sibling donor or HLA-haploidentical relatives of the patient, including biological parents, siblings, or children, half-siblings, cousins or aunts and uncles\n* Weight is greater than 30 kg\n* Age 12 and 50 years\n* Ability to undergo phlebotomy\n* Cardiac, renal, pulmonary, and hepatic function within normal limits\n* Complete blood count (CBC) with differential and platelet count within normal limits, and CMP within normal limits as deemed acceptable by the Principal Investigator and provider evaluating donor.\n* The familial donors should be able complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Recipient Exclusion Criteria:\n\n* Acute grade III-IV aGvHD or moderate\u002Fsevere chronic GvHD.\n* Requiring immunosuppression therapy for treatment of GvHD.\n* Co-morbidities: AST\u002FALT greater than 5 x ULN; Bilirubin greater than 2 x ULN; Creatinine greater than 2 x ULN for age or creatinine clearance\u002FGFR \\\u003C40 ml\u002Fmin\u002F1.73m2; Pulmonary function: DLCO less than 40% of normal or O2 Sat less than 92%; Cardiac: left ventricular ejection fraction less than 35%; active infection; HIV positive; Karnofsky score (adults) less than 60% or Lansky score less than 50% (pediatrics)\n* Uncontrolled or severe bacterial, fungal or viral infection.\n* Positive serum or urine pregnancy test for girls post menarche or women of childbearing age.\n* Severe psychiatric illness or mental deficiency making compliance to treatment unlikely and\u002For informed consent impossible.\n* Any reason, at the investigator's discretion, that the participation of the patient in this protocol would not be in patient's best interest, or where the patient would be unable to adhere to the study requirements.\n\nDLI Donor Exclusion Criteria:\n\n* Unable to perform graded exercise test\n* Cardiac or pulmonary disease restricting exercise\n* Positive anti-donor HLA antibody\n* Pregnant or lactating\n* Active infection\n* Positivity for HIV, hepatitis B (HBV), hepatitis C (HCV), human T-cell lymphotropic virus (HTLV-I\u002FII)\n* Severe psychiatric illness or mental deficiency making compliance with donation unlikely and\u002For informed consent impossible.",{"count":580,"type":21},94,[24],"The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone.\n\nWe hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).",[584,422,585,427,513,29],"Acute Lymphoid Leukemia","Acute Undifferentiated Leukemia (AUL)",[587,588,589,590,591,592,593,594],"Exercise","Donor Lymphocyte Infusion","Allogeneic Hematopoietic Stem Cell Transplantation","Hematologic Malignancies","Matched Sibling Donor","Haploidentical","Hematopoietic Cell Transplantation","DLI-X","2026-07-10",{"date":597,"type":49},"2026-07-13",{"date":599,"type":21},"2026-10-31",{"date":601,"type":21},"2030-06-01",{"name":603,"class":108},"University of Arizona",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":414,"sex":17,"minAge":610,"maxAge":611,"enrollmentInfo":612,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":613,"conditions":614,"keywords":618,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":109},"100583010","pre-malignant-states-to-hematologic-malignancies-in-firefighters-100583010","NCT06870760","Pre-malignant States to Hematologic Malignancies in Firefighters","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information.\n2. Age ≥ 40-49 years at the time of consent (self-reported)\n3. Ability of the participant to understand and comply with study procedures for the entire length of the study\n4. Currently employed by Charlotte Fire Department (CFD) with at least 5 years on-the -job experience (self-reported)\n\nExclusion Criteria:\n\nAnyone with a current diagnosis of a hematologic malignancy will be excluded.","40 Years","49 Years",{"count":503,"type":21},"The purpose of the study is to evaluate if firefighter exposure to hazardous compounds will increase the incidence of premalignant hematological states which subsequently increases the risk of the development of hematologic malignancies, and potentially other pathophysiological consequences.",[615,616,217,221,159,617],"Clonal Hematopoiesis of Indeterminate Potential","Monoclonal Gammopathy","Plasma Cell Disorder",[619,620,621],"Firefighters","CHIP","MGUS",{"date":597,"type":49},{"date":624,"type":49},"2026-06-23",{"date":626,"type":21},"2027-04",{"name":628,"class":108},"Wake Forest University Health Sciences",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":636,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":22,"phases":639,"briefSummary":640,"conditions":641,"keywords":645,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":652,"locationsCount":109},"100446836","phase-1-preliminary-safety-and-tolerability-of-cd19x22-car-t-cells-in-adolescent-and-adult-rr-b-nhl-patients-100446836","NCT05098613","Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R\u002FR B-NHL Patients","Phase 1 Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Adolescent and Adult Patients With Relapsed and\u002For Refractory B-Non-Hodgkin's Lymphoma (B-NHL)","Inclusion Criteria:\n\n1. Age: ≥ 16 years of age with no upper age limit. (NOTE: the first three subjects on this trial must be ≥ 18 years of age.)\n\nCOHORT 1: Non-CNS B-NHL\n\n1. Histologically confirmed aggressive B-cell NHL including the following types defined by World Health Organization (WHO) 2008:\n\n   1. Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified; T cell\u002Fhistiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr Virus (EBV)+ DLBCL of the elderly; OR\n   2. Primary mediastinal (thymic) large B cell lymphoma; OR\n   3. Transformation to DLBCL; OR\n   4. High grade B-cell Lymphoma (HGBL).\n2. Subjects must not have any signs or symptoms of CNS disease or detectable evidence of CNS disease on magnetic resonance imaging (MRI) at screening; subjects who have been previously treated for CNS disease, but have no evidence of disease at screening are eligible for this cohort.\n3. Subjects must have disease progression confirmed by either flow cytometry or immunohistochemistry (IHC), disease stabilization, or disease recurrence after at least two lines of therapy.\n\n   1. The two lines of prior therapy must include an anthracycline and anti-CD20 monoclonal antibody treatment.\n   2. Relapse or refractory after single antigen targeting CAR T cell therapy\n4. Must have evaluable or measurable disease according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma; lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n\nCOHORT 2: MANTLE CELL LYMPHOMA (MCL)\n\n1. Mantle Cell Lymphoma (MCL).\n\n   1. Results of all tests conducted on the tissue at initial diagnosis and\u002For relapse, including, but not limited to, the MCL subtype (classic and blastoid), Ki-67 proliferation index, and TP53 mutation status should be provided if done.\n2. Subjects must have relapsed and\u002For refractory MCL confirmed by either flow cytometry or immunohistochemistry (ICH), disease stabilization, or disease recurrence after at least two lines of therapy including any combination of the agents below:\n\n   1. An anti-CD20-directed therapy\n   2. A BTK inhibitor\n   3. Anthracycline or Bendamustine\n   4. Relapse or refractory after single antigen targeting CAR T cell therapy.\n3. Must have evaluable or measurable disease according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma; lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. MCL patients without measurable nodal or extranodal disease by IWG criteria are eligible if they have bone marrow involvement of MCL at relapse\n\nCOHORT 3: PRIMARY CNS LYMPHOMA OR SECONDARY CNS LYMPHOMA\n\n1. Subjects with relapsed and\u002For refractory primary CNS lymphoma (PCNSL) OR secondary CNS lymphoma (SCNSL), as defined by the following:\n\n   a. Absence of measurable disease outside the CNS, as determined by radiographic imaging (i.e. PET\u002FCT).\n\n   b. Detectable CNS disease, as defined as: i. At least 1 site of measurable disease within the brain or spinal cord that is ≥ 1 cm in the longest diameter based on MRI or PET\u002FCT imaging; OR, ii. CSF-positive disease only (confirmed by presence of persistent disease, detected by cytology or flow cytometry) at the time of enrollment iii. Neoplastic B-cells detectable within the vitreous by flow cytometry or cytology\n2. Subjects must have disease progression confirmed by either flow cytometry or immunohistochemistry (IHC), disease stabilization, or disease recurrence after at least one line of therapy.\n\nALL COHORTS:\n\n1. Subjects who have undergone autologous stem cell transplantation (SCT) with disease progression or relapse are eligible.\n2. Subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, are:\n\n   1. At least 100 days post-transplant,\n   2. Do not have active graft versus host disease (GVHD)\n3. Any standard of care systemic therapy prior to leukapheresis must follow the washout period.\n4. Any steroid use (dexamethasone or prednisone) prior to apheresis must follow the washout period. Physiological replacement doses are allowable with no washout period. Topical or inhaled steroids for localized GVHD is allowable.\n5. Peripheral blood CD3 count must be \\>0.15 x 10 (to the 6th) cells\u002FmL within 14 days prior to proceeding with apheresis.\n6. Toxicities from prior therapy must be stable and recovered to ≤ grade 1 (exceptions include non-clinically significant toxicities such as alopecia and the organ function definitions provided in inclusion criteria 12).\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, or Karnofsky ≥ 80%.\n8. Adequate organ function as defined by:\n\n   1. Absolute neutrophil count (ANC) ≥ 500\u002FμL\n   2. Platelet count ≥ 50,000\u002F μL.\n   3. Renal: Creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by Cockcroft Gault equation) ≥ 60 mL\u002Fmin.\n   4. Hepatic: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN).\n   5. Total bilirubin ≤ 2 mg\u002Fdl, except in subjects with Gilbert's syndrome where a bilirubin \\\u003C4.0 will be acceptable.\n   6. Cardiac: Ejection fraction ≥ 40%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings within 6 weeks of apheresis.\n   7. Pulmonary: No clinically significant pleural effusion and;\n\n   i. Baseline oxygen saturation must be \\> 92% on room air\n9. Females of childbearing potential must have a negative serum pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 6 months are not considered to be of childbearing potential).\n10. Subjects of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the CD19x22 infusion; females of childbearing potential must have a negative pregnancy test.\n\n21\\. Must be able to give informed consent; subjects unable to give informed consent will not be eligible for this study.\n\n22\\. Be able to consent to long-term follow-up protocol (#20-0188).\n\nExclusion Criteria:\n\n1. Age \\\u003C 16 years of age.\n2. Patients who are intolerant of contrast-enhanced MRI due to allergic reactions to contrast agents. Only applicable to Cohort 3.\n3. Patients with active, poorly controlled hydrocephalus defined as increase\u002Fworsening in symptoms (headaches, nausea\u002Fvomiting, lethargy, or neurological function with increased hydrocephalus noted on radiologic evaluation and\u002For need for CSF diversion. Note: If hydrocephalus is controlled after CSF diversion, patient may be eligible for the study. Only applicable to Cohort 3.\n4. Patients with brainstem lesions. Only applicable to Cohort 3.\n5. History of other malignancies, unless they have been disease free for at least 3 years. Exceptions include non-melanoma skin cancer or carcinoma in situ and localized prostate cancer not on active treatment.\n6. Uncontrolled fungal, bacterial, viral, or other infection requiring antimicrobials for management; uncomplicated infections are permitted if responding to active treatment.\n7. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive) or hepatitis C.\n8. History of known myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment or have cardiac atrial or cardiac ventricular lymphoma involvement.\n9. Venous thrombosis or embolism not managed on a stable regimen of anticoagulation.\n10. Any medical condition that in the judgement of the sponsor is likely to interfere with assessment of safety or efficacy of study treatment.\n11. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n12. Pregnancy (serum pregnancy test must be obtained at time of enrollment for females of childbearing potential and to be repeated 72 hours prior to lymphodepleting chemotherapy regimen); females who have undergone surgical sterilization or who have been postmenopausal for at least 6 months are not considered to be childbearing potential.\n13. Lactating.\n14. 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.\n15. Unwilling to participate in long-term follow-up protocol that is required if CAR T cell therapy is administered at CU Anschutz.\n\nAPHERESIS ELIGIBILITY\n\nIn order to proceed with apheresis, enrolled participants cannot have active, severe infection. For the purpose of this trial, active, severe infection is defined as:\n\n* Positive blood culture within 48 hours of the start of the apheresis procedure, OR\n* Fever \\>38.2°C AND clinical signs of infection within 48 hours of start of apheresis procedure\n\nAdditionally, participants should have the following labs within 14 days of apheresis:\n\n* CBC with manual differential\n* Lymphocyte enumeration (TBNK) panel to measure CD3 count\n\n  * CD3 count must be \\>0.15 x 106 cells\u002FmL\n\nLYMPHODEPLETING CHEMOTHERAPY ELIGIILITY:\n\nIn order to proceed with lymphodepleting chemotherapy, enrolled participants must meet all eligibility criteria below within 72 hours prior to lymphodepletion, unless otherwise specified:\n\n* If the participant received bridging therapy after apheresis, confirmation of disease reevaluation is required. It must be within 6 weeks of initiation of LD chemotherapy.\n\n  * Confirmation that the participant has met the washout period for bridging therapy.\n* Negative serum pregnancy test (for women of childbearing potential)\n* Adequate organ function as defined by:\n\n  * Absolute neutrophil count (ANC) ≥ 500\u002FμL.\n  * Platelet count ≥ 50,000\u002F μL.\n  * Renal: Creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by Cockcroft Gault equation) ≥ 60 mL\u002Fmin.\n  * Hepatic: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN).\n  * Total bilirubin ≤ 2 mg\u002Fdl, except in subjects with Gilbert's syndrome where a bilirubin \\\u003C3.0 will be acceptable.\n  * Pulmonary: No clinically significant pleural effusion and; Baseline oxygen saturation must be \\> 92% on room air.\n  * Cardiac: Ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO) (only if subject received bridging anthracycline or developed a significant illness prior to LD-chemo per investigator assessment.) If clinically indicated, ECHO must be performed within 2 weeks prior to LD-chemotherapy.\n* Cohort 3 patients ONLY:\n\n  * Patients must not have steroid-dependent CNS lymphoma, defined as requiring more than 1 mg\u002Fkg\u002Fday or prednisone or equivalent within 14 days prior to the start of LD chemotherapy.\n  * Patients may not have poorly controlled hydrocephalus prior to the initiation of LD chemotherapy.\n\nCD19x22 CAR T CELL INFUSION ELIGIBILITY\n\nIn order to proceed with CD19x22 CAR T Cell Infusion, enrolled participants must meet all eligibility criteria below within 24 hours prior to CD19x22 CAR T Cell infusion, unless otherwise specified:\n\n* CD19x22 CAR T cells must have met manufacturing release criteria (unless prospectively approved by IND Sponsor, Gates Institute Medical Lead, and FDA).\n* Confirmation that the site has Anakinra and Ruxolitinib in stock and available (should IEC-HS treatment be required).\n* ECOG ≤2 or Karnofsky≥ 50%.\n* Clinically stable without evidence of vital sign instability, including the lack of supportive vasoactive drugs or intensive care unit support.\n* Oxygen saturation \\> 92% on room air; cannot be on supplemental oxygen.\n* No evidence of uncontrolled, significant tumor lysis syndrome prior to cell infusion per investigator assessment.\n* No evidence of rapidly progressive NHL per investigator determination.\n* Participants' temperature is \\\u003C38.0 °C within 48 hours prior to cell infusion. (If the source of fever cannot be identified \\[after thorough infectious disease work-up\\], and the suspected cause is underlying malignancy, discussion and approval by the Gates Institute Medical Lead may allow continued infusion of CD19x22 cells. This should be appropriately documented in the patient's medical record.\n* Liver transaminase (ALT and AST) \\\u003C 5 x institutional ULN (\\\u003C grade 3) based on age- and laboratory- specific normal ranges.\n* Adequate renal function as defined by creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by the Cockcroft- Gault equation) ≥ 60 mL\u002Fmin.\n\nIf these criteria are not met, measures can be taken to resolve the underlying condition(s). If successful, cells may be infused up to (and including) 7 days following the time of the planned infusion with no additional lymphodepletion. If the CD19x22 CAR T Cell infusion is delayed more than 7 days, lymphodepleting chemotherapy MAY be repeated, per the investigator's discretion. Prior to commencing a second round of lymphodepletion, participants must meet lymphodepletion criteria described above.","16 Years",{"count":638,"type":21},68,[24],"This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed\u002Frefractory (R\u002FR) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.",[29,642,643,644],"B-cell Non-Hodgkin Lymphoma (B-NHL)","Mantle Cell Lymphoma (MCL)","CNS Lymphoma",[161,160],"2026-07-07",{"date":648,"type":49},"2026-07-09",{"date":650,"type":49},"2021-12-21",{"date":196,"type":21},{"name":653,"class":108},"University of Colorado, Denver",{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":22,"phases":663,"briefSummary":664,"conditions":665,"keywords":668,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":677,"locationsCount":494},"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":662,"type":21},15,[24],"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.",[217,666,73,215,667,34,71,72,33,30],"B-cell Non Hodgkin Lymphoma","Primary Mediastinal Large B Cell Lymphoma",[669,670],"NK cells","Natural Killer cells","2026-07-06",{"date":673,"type":49},"2026-07-08",{"date":675,"type":21},"2026-09",{"date":196,"type":21},{"name":678,"class":108},"Paolo Caimi, MD",{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":684,"acronym":4,"eligibilityCriteria":685,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":686,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":688,"conditions":689,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":713},"100159702","a-multicenter-access-and-distribution-protocol-for-unlicensed-cryopreserved-cord-blood-units-cbus-100159702","NCT01351545","A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)","A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications","Inclusion Criteria:\n\n* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment\n* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment\n* Pediatric and adult patients of any age\n\nExclusion Criteria:\n\n* Patients who are receiving only licensed CBUs\n* Cord blood transplant recipients at international transplant centers\n* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)\n* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated",{"count":687,"type":21},99999,"This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.",[590,690,691,692,693,694,695,696,697,698,425,94,699,700,701,702,703],"Inherited Disorders of Metabolism","Inherited Abnormalities of Platelets","Histiocytic Disorders","Acute Myelogenous Leukemia (AML or ANLL)","Acute Lymphoblastic Leukemia (ALL)","Other Acute Leukemia","Chronic Myelogenous Leukemia (CML)","Myelodysplastic (MDS) \u002F Myeloproliferative (MPN) Diseases","Other Leukemia","Multiple Myeloma\u002F Plasma Cell Disorder (PCD)","Inherited Abnormalities of Erythrocyte Differentiation or Function","Disorders of the Immune System","Autoimmune Diseases","Severe Aplastic Anemia","2026-07-01",{"date":671,"type":49},{"date":707,"type":4},"2011-10",{"date":709,"type":21},"2041-10",{"name":711,"class":712},"Center for International Blood and Marrow Transplant Research","NETWORK",142,{"id":715,"slug":716,"hasResults":12,"nctId":717,"briefTitle":718,"officialTitle":719,"acronym":720,"eligibilityCriteria":721,"healthyVolunteers":12,"sex":17,"minAge":722,"maxAge":4,"enrollmentInfo":723,"targetDuration":4,"studyType":22,"phases":725,"briefSummary":726,"conditions":727,"keywords":732,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":737,"lastUpdatePostDateStruct":738,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":109},"100615412","halt-aging-in-survivors-of-blood-cancers-100615412","NCT07292272","Halt Aging in Survivors of Blood Cancers","Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study","HALTAging-1","Inclusion Criteria:\n\n1. Age ≥50 years\n2. A history of hematological malignancy\n3. Participants must be able to and willingly give informed consent\n\nExclusion Criteria:\n\n1. Patients receiving intensive induction or consolidation chemotherapy. Maintenance chemotherapy, or lower-intensity chemotherapy for an indolent hematological malignancy is allowed.\n2. Neurodegenerative disease (e.g. Alzheimer's dementia), stroke, or uncontrolled psychotic disorders (e.g. schizophrenia or bipolar disorder) in the past 3 months if those disorders are considered significant enough to impair participation in the study.\n3. Illnesses such as clinical evidence of decompensated heart failure, unstable angina, or orthopedic or neuromuscular disorders that could limit safe participation in aerobic exercise.\n4. Cardiopulmonary exercise test results that preclude safe exercise (e.g., life-threatening arrhythmia, balance difficulties, peak VO2 \\\u003C10 ml\u002Fkg\u002Fmin).\n5. Estimated life expectancy of less than 6 months (that precludes assessment of study primary endpoint).\n6. Self-reported pregnancy or the possibility of pregnancy.\n7. Participants who do not plan to follow up at the participating center.","50 Years",{"count":724,"type":21},180,[505],"Older survivors of blood cancer are at a high risk of accelerated biological aging, which increases their risk of developing multiple aging-related conditions. Whereas physical exercise can improve overall health, older cancer survivors do not meet the recommended physical activity, highlighting the need to develop behavioral interventions to increase adherence. Several other knowledge gaps exist to implement exercise interventions in older survivors of blood cancer; the dose and duration of exercise necessary to slow biological aging in older blood cancer survivors remain unknown. To bridge these gaps in knowledge, we have designed a Phase 2 randomized control trial to test the effects of behavioral and exercise interventions on various outcomes.",[728,221,556,159,729,730,94,731],"Hematological Malignancy","Myeloid Leukemia","Monocytic Leukemia","Other Hematologic Condition",[425,221,556,159,729,730,94,731,733,734,735,736],"Epigenetic clock","Biological aging","Quality of life","Blood cancer survivors","2026-06-29",{"date":704,"type":49},{"date":740,"type":49},"2026-04-09",{"date":742,"type":21},"2033-03-25",{"name":744,"class":108},"University of Nebraska",{"id":746,"slug":747,"hasResults":12,"nctId":748,"briefTitle":749,"officialTitle":750,"acronym":4,"eligibilityCriteria":751,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":752,"targetDuration":4,"studyType":22,"phases":753,"briefSummary":754,"conditions":755,"keywords":759,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":763,"lastUpdatePostDateStruct":764,"startDateStruct":766,"completionDateStruct":768,"leadSponsor":770,"locationsCount":109},"100469178","phase-1-pomalidomide-and-dose-adjusted-epoch---rituximab-for-hiv-associated-lymphomas-100469178","NCT05389423","Pomalidomide and Dose-Adjusted EPOCH +\u002F- Rituximab for HIV-Associated Lymphomas","Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +\u002F- Rituximab for HIV-Associated Lymphomas","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed B-cell NHL confirmed by the Laboratory of Pathology (LP), NCI, with one or more of the following features:\n\n  * Leptomeningeal\u002FCSF involvement\n  * High-risk for CNS relapse per CNS-IPI (score 4-6)\n  * Plasmablastic histology\n  * Gamma herpesvirus positive tumor\n  * Presence of KS\n* Measurable or evaluable lymphoma.\n* Positive HIV1\u002F2 serology.\n* Individuals may not have received prior curative-intent chemotherapy for lymphoma. Individuals who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if \\>= 2 weeks since administration. Steroids given for any reason or rituximab given for multicentric Castleman disease may be given any time prior to treatment start.\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group performance status (ECOG-PS) \\\u003C=4\n* Individuals of childbearing potential (IOCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 2 weeks prior to and again within 1 day before starting the study drugs and must either commit to continued abstinence from penetrative vaginal 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 the participant starts taking pomalidomide and for 12 months after the last dose of combined chemotherapy.\n* Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to six (6) months after the last dose of the study drug(s). We also will recommend individuals able to father a child with IOCBP partners to ask the partners to be on an effective birth control (hormonal, intrauterine device (IUD), surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.\n* All individuals must agree to be registered into the mandatory POMALYST REMS(R)TM program and be willing and able to comply with the requirements of the POMALYST REMS(R)TM program.\n* Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis.\n* Adequate organ and marrow function as defined below unless abnormalities are attributed to lymphoma or HIV as determined by investigator:\n\n  * absolute neutrophil count \\>=1,000\u002FmcL\n  * platelets \\>=75,000\u002FmcL\n  * total bilirubin \\\u003C=1.5 X institutional upper limit of normal (individuals with history of Gilbert disease are eligible if total bilirubin \\\u003C= 5 mg\u002FdL with \\\u003C80% unconjugated bilirubin)\n  * aspartate aminotransferase (AST) \u002F alanine transaminase (ALT) \\\u003C=3 X institutional upper limit of normal\n  * creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for individuals with creatinine levels above institutional normal.\n* Hepatitis B virus (HBV) infection must be on suppressive antiviral therapy.\n* Willingness to take and adhere to ART (individuals are not required to be on any specific regimen of ART).\n* Individuals must understand and sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Individuals may not receive investigational agents on other clinical trials.\n* Requirement of any of the agents listed as prohibited thearapies.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study.\n* Parenchymal brain involvement with lymphoma.\n* Ejection fraction less than 40% by echocardiography (ECHO)\n* CTCAEv5.0 Grade 3-4 neuropathy\n* History of malignant tumors other than KS or KSHV-associated multicentric Castleman Disease, (MCD), unless:\n\n  * In complete remission for \\>= 1 year from the time response was first documented; or,\n  * Completely resected basal cell carcinoma; or,\n  * In situ squamous cell carcinoma of the cervix or anus; or,\n  * Prior or concurrent malignancy has a natural history or treatment which does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per Protocol Chair discretion.\n* Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.\n* Symptomatic congestive heart failure\n* Unstable angina pectoris, symptomatic cardiac arrhythmia, or cardiac arrhythmia requiring medical treatment.\n* Uncontrolled intercurrent illness or participants considered to be of poor medical health due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection (excluding lymphoma or HIV) as documented in prior records or suggested by medical history, physical examination or standard clinical assessments such as imaging and laboratory studies.\n* Pregnant or nursing individuals (if lactating, must agree not to nurse while taking pomalidomide).",{"count":7,"type":21},[24],"Background:\n\nNon-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. More study is needed for treating\n\npeople with both HIV and NHL.\n\nObjective:\n\nTo test a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated NHL.\n\nEligibility:\n\nAdults aged 18 years or older diagnosed with HIV-associated B-cell NHL with high-risk features.\n\nDesign:\n\nIndividuals will undergo screening. They will have a physical exam. They will have blood and urine tests and tests of heart function. They may have imaging scans. Researchers will review tissue samples of individual s tumors. In some cases, a new biopsy may be needed.\n\nIndividuals will receive up to 6 cycles of treatment.\n\nThe first cycle is 26 days: Individuals will take pomalidomide by mouth for 10 days. After 5 days they will start receiving chemotherapy drugs through a tube attached to a needle placed in a vein (IV). Some participants will receive rituximab on day 5. All individuals will receive a second set of IV drugs that will last for 4 days (96 hours). They will receive another IV drug after the previous treatment is complete.\n\nThe remaining cycles are each 21 days. Individuals will take pomalidomide by mouth for the first 10 days. Other chemotherapy treatments will also be repeated starting on day 1 of each cycle.\n\nScreening tests will be repeated at study visits.\n\nFollow-up visits will continue for 4 years....",[756,29,125,757,758],"Diffuse Large Cell Lymphoma","Plasmablastic Lymphoma","B-Cell Neoplasm",[29,760,757,761,762],"Epstein Barr Virus","Chemotherapy","Immune Modulatory","2026-06-27",{"date":765,"type":49},"2026-06-30",{"date":767,"type":49},"2023-06-27",{"date":769,"type":21},"2032-06-01",{"name":137,"class":138}]