[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"follicular-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:follicular-lymphoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,87,0,25,[9,42,79,103,126,148,179,204,230,253,275,305,333,368,404,432,459,485,531,549,573,613,648,671,696],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100641666","phase-2-a-clinical-trial-of-mk-1045-and-rituximab-in-people-with-follicular-lymphoma-mk-1045-007-100641666",false,"NCT07634471","A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)","A Phase 2\u002F3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma","Inclusion Criteria:\n\n* Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.\n* Has radiographically measurable disease per the Lugano Response Criteria.\n* Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.\n* If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.\n* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Has received prior systemic anticancer therapy or radiotherapy for FL.\n* Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.\n* Has FL that has transformed into a more aggressive type of lymphoma.\n* History or presence of clinically relevant central nervous system (CNS) diseases.\n* Has history of serious cardiovascular and cerebrovascular diseases.\n* Is HIV-infected with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known active CNS lymphoma or involvement.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has active infection requiring systemic therapy.\n* Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.","ALL","18 Years",{"count":20,"type":21},960,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy.\n\nThe goals of this study are to learn:\n\n* About the safety of MK-1045 and rituximab, and if people tolerate them when given together\n* If people who receive MK-1045 and rituximab have the cancer go away\n* If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)",[28],"Follicular Lymphoma","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2026-06-22",{"date":37,"type":21},"2035-07-23",{"name":39,"class":40},"Merck Sharp & Dohme LLC","INDUSTRY",19,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":63,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100461905","phase-1-treatment-of-chinese-participants-with-b-cell-malignancies-with-bgb-16673-a-bruton-tyrosine-kinase-targeted-protein-degrader-100461905","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",{"count":50,"type":21},146,[52,24],"PHASE1","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",[55,56,57,58,59,60,28,61,62],"B-cell Malignancy","Non-Hodgkin Lymphoma","Mantle Cell Lymphoma","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Waldenström Macroglobulinemia","Marginal Zone Lymphoma","DLBCL Unclassifiable","Richter's Transformation",[55,64,65,66,62,67,68,69,70],"MZL","FL","DLBCL","CDAC","BTK","degrader","BGB-16673",{"date":32,"type":33},{"date":73,"type":33},"2022-05-06",{"date":75,"type":21},"2029-01-31",{"name":77,"class":40},"BeiGene",29,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"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":88,"type":21},645,[52,24],"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)",[55,60,28,56,59,92,93,57,94],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Diffuse Large B Cell Lymphoma",{"date":32,"type":33},{"date":97,"type":33},"2021-09-13",{"date":99,"type":21},"2029-11",{"name":101,"class":40},"BeOne Medicines",115,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100423334","phase-2-mosunetuzumab-with-lenalidomide-augmentation-as-first-line-therapy-for-follicular-and-marginal-zone-lymphoma-100423334","NCT04792502","Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma","BrUOG 401: A Phase 2 Study of Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.\n2. Age ≥18 years at the time of signing informed consent. Because no dosing or adverse event data are currently available on the use of mosunetuzumab in patients \\\u003C18 years of age, they are excluded from this study.\n3. Histologically confirmed diagnosis of:\n\n   * follicular lymphoma (grade 1, 2, 3a, or not otherwise specified) or\n   * marginal zone lymphoma (nodal, extranodal, or splenic), according to 2016 WHO classification and confirmed to express the CD20 antigen by immunohistochemistry or flow cytometry. Patients in whom definitive pathologic subtype of FL\u002FMZL is undetermined due to limited biopsy material can be enrolled if in the investigator's opinion integrated clinicopathologic data are consistent with the eligible diagnosis.\n4. Agreement to provide, if available, lymphoma tissue for correlative analyses.\n5. At least one bi-dimensionally measurable nodal lesion, defined as \\>1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \\>1.0 cm in its longest diameter; with the exception of splenic MZL, which must be evaluable using the International SMZL Group criteria.\n6. No prior systemic therapy for B-cell lymphoma, except for palliative corticosteroids; prior local therapy (surgery, radiation therapy, or antibiotics) is allowed.\n7. Indication to start systemic therapy for lymphoma:\n\n   * Patients with FL must meet one of the GELF criteria:\n\n     * any mass ≥7 cm (except spleen);\n     * at least 3 nodes \\>3 cm in diameter;\n     * symptomatic spleen enlargement;\n     * local symptoms or compromise of normal organ function due to tumor mass;\n     * presence of ascites or pleural effusion;\n     * presence of B symptoms (fever, night sweats, or unintentional weight loss of \\>10% over ≤6 months);\n     * serum lactate dehydrogenase or beta-2-microglobulin above upper limit of normal;\n     * cytopenias due to underlying lymphoma (i.e., absolute neutrophil count \\\u003C1.0 × 109\u002FL, hemoglobin \\\u003C10 g\u002FdL, and\u002For platelet count \\\u003C100 × 109\u002FL).\n   * Patients with MZL must have an indication to start therapy as assessed by the investigator.\n8. Performance status ECOG 0, 1, or 2.\n9. Adequate hematologic function (unless due to underlying lymphoma as established by bone marrow involvement or splenomegaly):\n\n   * hemoglobin ≥9 g\u002FdL,\n   * absolute neutrophil count ≥1.0 x 109\u002FL,\n   * platelet count ≥75 x 109\u002FL.\n10. Glomerular filtration rate (GFR) ≥40 mL\u002Fmin\u002F1.73m2 using the Mayo Quadratic Formula.\n11. The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because lenalidomide used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) and refrain from donating eggs or sperm throughout the treatment and for 3 months after the last dose of trial therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n12. Agreement to enroll in and comply with all local requirements of the REVLIMID® (lenalidomide) Risk Evaluation and Mitigation Strategy (REMS®) program for the purpose of lenalidomide acquisition.\n\nExclusion Criteria:\n\n1. Grade 3b follicular lymphoma or transformed lymphoma.\n2. Prior treatment with any anti-CD20 antibody or lenalidomide for lymphoma.\n3. Prior stem cell transplantation (autologous or allogeneic) or prior solid organ transplantation.\n4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.\n5. Known NYHA class 3\u002F4 congestive heart failure, LVEF \\\u003C40%, myocardial infarction within 6 months prior to enrollment, unstable angina, or unstable arrhythmia.\n6. Chronic obstructive pulmonary disease (COPD) requiring oral corticosteroids or chronic oxygen.\n7. History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, idiopathic pulmonary fibrosis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, granulomatosis with polyangiitis, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the exception of: hypothyroidism (on stable dose of thyroid replacement therapy), asthma managed with inhaled medications only; type 1 diabetes mellitus on stable insulin regimen, Sjögren syndrome, immune thrombocytopenia or autoimmune hemolytic anemia that does not require systemic therapy; dermatologic condition (including eczema, psoriasis, lichen simplex chronicus, or vitiligo) with skin manifestations with rash covering \\\u003C10% of body surface area and not requiring treatment other than low-potency topical corticosteroids for \\>12 months prior to registration.\n8. Use of any systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment using \\\u003C10 mg\u002Fday prednisone or equivalent within 2 weeks prior to first treatment; a brief course of palliative corticosteroids at higher doses (prednisone up to 100 mg daily, for up to 7 days) is allowed, but must be completed at least 7 days before the first dose of mosunetuzumab.\n9. Any of the following conditions:\n\n   * active bacterial infection requiring antibiotics\n   * known or suspected chronic active Epstein Barr virus (CAEBV) infection\n   * history of hemophagocytic lymphohistiocytosis (HLH)\n   * confirmed progressive multifocal leukoencephalopathy (PML)\n   * known active EBV or CMV viremia\n   * positive test for hepatitis B surface antigen (HBSAg). Patients with a positive total\u002FIgG hepatitis B core antibody (HBcAb) may participate if hepatitis B virus (HBV) DNA is undetectable at screening, if they agree to take entecavir or tenofovir, and undergo periodic DNA testing\n   * positive hepatitis C virus (HCV) antibody, unless a negative polymerase chain reaction (PCR) for HCV is documented\n   * positive test for HIV.\n10. Administration of a live, attenuated vaccine within 4 weeks before first mosunetuzumab dose or anticipation that such a live, attenuated vaccine will be required during the study.\n11. Current or past history of CNS disease, including stroke, epilepsy, or CNS vasculitis, or an advanced neurodegenerative disease; with the exception of: stroke \\>2 years before registration without any residual neurologic deficits and no subsequent transient ischemic attacks; history of epilepsy with no seizures for \\>2 years and not using any antiepileptic therapy; well-controlled Parkinson's disease (with no need for a significant medication adjustment for \\> 6 months).\n12. History of other malignancy that could affect compliance with the protocol or interpretation of results; patients with a curatively treated skin cancer, in situ cervical cancer, or another malignancy treated curatively with a documented remission \\>2 years before registration are eligible.\n13. 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 within 4 weeks before the first dose of mosunetuzumab.\n14. Clinically significant liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.\n15. Any major surgery within 4 weeks before the first dose of mosunetuzumab, other than lymph node biopsy for diagnosis.\n16. Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol.\n17. Any of the following abnormal laboratory values within 14 days prior to first dose of mosunetuzumab:\n\n    * AST or ALT \\>3x ULN\n    * total bilirubin \\>2 x ULN (unless due to Gilbert syndrome with indirect hyperbilirubinemia only)\n    * INR\\>1.5 x ULN without anticoagulation\n    * PTT or APTT \\>1.5x ULN in the absence of lupus anticoagulant.\n18. Any radiation therapy within 2 weeks prior to first dose of mosunetuzumab.\n19. Pregnancy, breast-feeding, or prisoner status. Women of childbearing potential must have a negative pregnancy test within 2 weeks before first dose of mosunetuzumab, and must undergo repeat pregnancy testing during each cycle of lenalidomide therapy (see Inclusion Criterion 11).",{"count":111,"type":21},52,[24],"BrUOG-401 is a prospective, single-arm, phase 2 trial of first-line therapy in adult patients with previously untreated FL or MZL. All patients will be assigned the same initial treatment plan, modified by interim response assessment (IRA) after Cycle 4. All patients will start treatment with four 21-day cycles (C1-4) of mosunetuzumab alone (using step-up dosing during C1), followed by IRA. Patients who achieve CR at IRA will continue with additional 4 cycles (C5-8) of mosunetuzumab. Patients who achieve PR at IRA will receive mosunetuzumab with lenalidomide augmentation during C5-8. Primary response assessment (PRA) will occur after C8. Patients who remain in PR at PRA will continue for additional 4 cycles (extended augmentation).",[28,60,115],"B-cell Lymphoma","2026-08-19",{"date":30,"type":33},{"date":119,"type":33},"2022-07-14",{"date":121,"type":21},"2027-08-31",{"name":123,"class":124},"Brown University","OTHER",3,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100577017","phase-2-hm2023-43ph-2-trial-of-tafasitamab-with-lenalidomiderituximab-in-treatment-naive-fl-and-mzl-100577017","NCT06792825","HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL","HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed marginal zone lymphoma\n* Histologically confirmed CD20+ follicular lymphoma stage 1, 2 or 3a\n* No prior systemic therapy for lymphoma\n* Must be in need of treatment as evidenced by one or more of the following criteria:\n* Bulky disease defined as:\n* a nodal or extranodal (except spleen) mass \\>7cm in its greater diameter or,\n* involvement of at least 3 nodal or extranodal sites (each with a diameter greater than \\>3 cm)\n* Presence of at least one of the following B symptoms:\n* fever (\\>38C) of unclear etiology\n* night sweats\n* weight loss greater than 10% within the prior 6 months\n* Any other symptoms attributable to lymphomatous mass\n* Endangerment of vital organ due to lymphomatous mass including but not limited to:\n* Symptomatic or massive splenomegaly\n* Compression syndrome (including but not limited to ureteral, orbital, gastrointestinal)\n* Pleural, pericardial or ascitic effusion regardless of cell count\n* Follicular lymphoma in leukemic phase (\\>5 X 109\u002FL circulating cells)\n\nOR:\n\n* Follicular lymphoma graded high-risk by FLIPI2 score (see Appendix III)\n* Adequate organ function within 14 days (28 days for pulmonary or cardiac) of study registration\n* Participants who are of childbearing potential or have partners of child-bearing potential must agree to either total abstinence or use of both a highly effective (IUD, hormonal contraceptives, tubal ligation or vasectomy), and effective contraception (male or female condom, diaphragm or cervical cap) for the duration of treatment and for 12 months after the last dose of study drug.\n* Able to tolerate prophylactic anticoagulation\u002Fantiplatelet therapy while on lenalidomide\n* Able to provide written voluntary consent prior to the performance of any research related tests or procedures (or the subject's legally authorized representative (LAR) if enrollment of persons with diminished capacity is permitted - general permitted for Phase II and greater studies)\n\nExclusion Criteria:\n\n* Seropositive for or active viral infection with hepatitis B virus (HBV):\n* HBV surface antigen (HBsAg) positive\n* HBV surface antigen (HBsAg) negative, HBV surface antibody (anti-HBs) positive and\u002For HBV core antibody (anti-HBc) positive, and detectable viral DNA\n* Hepatitis C virus (HCV) positive subjects with chronic hepatitis C, or subjects with an active hepatitis C infection requiring anti-viral medication (at time of randomization).\n* Known seropositive for or active viral infection with human immunodeficiency virus (HIV).\n* Prior history of lenalidomide use\n* Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.\n* Peripheral neuropathy ≥ grade 2 at time of screening\n* Uncontrolled intercurrent illness.\n* Active infection (requiring systemic therapy) or has received a live vaccine within 14 days prior to first dose of study drug.\n* Presence or history of CNS involvement by lymphoma\n* Patients who are not willing to take venous thromboembolic (VTE) prophylaxis or antiplatelet therapy\n* Recent ( \\\u003C1 year ) arterial thrombosis (any) or venous thrombosis ≥ grade 3 by CTCAE 5.0.\n* Pregnant or breastfeeding as agents used in this study are Pregnancy Category X.\n\nWomen of childbearing potential must have two negative pregnancy tests (serum or urine) prior to their first dose of lenalidomide, and must agree to scheduled pregnancy testing while on treatment regardless of their birth control choice, per the requirements of the lenalidomide risk evaluation and mitigation strategy (REMS) program.",{"count":134,"type":21},65,[24],"The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-naïve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.",[28,60],"2026-08-10",{"date":140,"type":33},"2026-08-12",{"date":142,"type":33},"2025-08-07",{"date":144,"type":21},"2031-07-08",{"name":146,"class":124},"Masonic Cancer Center, University of Minnesota",1,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":147},"100542274","phase-1-autologouscd22-chimeric-antigen-receptor-cart-cells-in-wrecurrentrefractory-b-cell-lymphomas-100542274","NCT06340737","AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w\u002FRecurrent\u002FRefractory B Cell Lymphomas","Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Lymphomas","Inclusion Criteria:\n\n* Disease: Must have histologically confirmed disease as defined by WHO 2016\\[117\\] of one of the following:\n\nFollicular Lymphoma, grade 1-3a\n\n1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy (single-agent anti- CD20 antibody does not count as line of therapy for eligibility nor does local radiation). Anti-CD20 antibody is not required for participants with CD20 negative disease. A systemic therapy includes, but is not limited to: Bendamustine, CHOP, CVP, CART therapy, lenalidomide, or platinum-based chemotherapy.\n2. Relapsed or progressive disease within 24 months of initiation of the initial course of chemotherapy (also known as progression of disease within 24 months POD24). Initial treatment must have included an anti-CD20 monoclonal antibody (unless CD20 negative) plus either Bendamustine, CHOP or CVP (R-Chemo). Must have completed 3 or more cycles of R-Chemo. Progression is measured from the initial day of treatment of the first cycle of R-Chemo. In the case of those who received anti-CD20 monoclonal antibody monotherapy previously and then received R-Chemo are also eligible if they are POD24, and progression is measured from the initial day of treatment of the first cycle of R-Chemo and not from the initial day of anti-CD20 monoclonal antibody monotherapy.\n\nMantle Cell Lymphoma 1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy. Anti-CD20 antibody is not required for participants with CD20negative disease.\n\n2\\. Participants who have received an anti-CD20 monoclonal antibody in combination with chemotherapy AND a Bruton's Tyrosine Kinase inhibitor as a single line of therapy are also eligible.\n\nHairy cell leukemia (HCL)\n\n1. Diagnosis of HCL and require treatment as defined by having HCL-related anemia (hemoglobin \\\u003C11 g\u002FdL), thrombocytopenia (platelets\\\u003C100 x 10\\^9 \u002FL), or neutropenia (absolute neutrophil count below 1.5 x 10\\^9\u002FL); symptomatic splenomegaly or adenopathy; or other constitutional symptoms directly related to HCL;\n2. Must have progressed or been refractory to 2 lines of therapy including a purine nucleoside analog.\n\nLymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia (WM)) - participants must meet all eligibility criteria listed\n\n1\\. Must have confirmed diagnosis of WM based on Second International Workshop on WM 2. Relapsed or refractory disease after 2 or more lines of therapy\n\n1\\. Prior therapies must include a i. BTKi ii. either chemotherapy and\u002For proteasome inhibitor 3. Requires treatment based on the recommendations from the Second International Workshop on WM 4. Requires the presence of serum IgM that is at least 2 times the upper limit of normal 5. Patients cannot require plasmapheresis for symptomatic hyperviscosity. 6. Patients cannot have symptomatic central nervous system involvement (Bing-Neel syndrome) that would prevent the assessment of neurotoxicity 7. Patients cannot have transformed to large B cell lymphoma Burkitt lymphoma (BL)\n\n1\\. Relapsed or refractory to front line chemoimmunotherapy; Participants with high-grade B-cell lymphoma with MYC and BCL2 and\u002ForBCL6 rearrangements will be excluded.\n\nMarginal zone lymphoma (MZL)\n\n1\\. Must have received 2 prior lines of therapy including rituximab in combination with chemotherapy or a BTKi\n\nHistologically confirmed Large B-cell lymphoma (LBCL) by WHO 2008 including:\n\ni. DLBCL not otherwise specified; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR ii. primary mediastinal (thymic) large B cell lymphoma; OR iii. transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma to DLBCL; OR iv. Follicular Lymphoma Grade 3B\n\n• Subjects with DLBCL, Follicular Lymphoma Grade 3B -or-\n\nSubjects with transformed FL and MZL who HAVE NOT received chemotherapy prior to transformation:\n\n1\\) Must have received an anthracycline regimen and an anti CD20 monoclonal antibody (unless documented CD20-negative) and be refractory or relapsed after second line of LBCL treatment. Subjects with a partial response to second line therapy must be ineligible for autologous transplant.\n\n* Subjects with transformed FL and MZL who HAVE received anthracycline-containing chemotherapy prior to transformation must have progressed, had SD or recurred with transformed disease after initial treatment for LBCL:\n\n  1. Must have progressed, had SD, or recurred with transformed disease after initial treatment for LBCL\n\n     Note: T cell\u002Fhistiocyte rich large B cell lymphoma is not eligible\n\n     The following criteria apply to all participants unless otherwise noted:\n\n  2\\. Measurable Disease:\n  1. a. Participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma and Marginal Zone Lymphoma must have measurable disease according to the revised 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\n     b. If participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma, Marginal Zone Lymphoma, and Large B cell Lymphoma that do not have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma, but have disease that is greater than 2% of events by flow cytometry in the peripheral blood or bone marrow will be eligible\n  2. c. Participants with Hairy Cell Lymphoma must have presence of leukemic cells in the bone marrow or blood stream.\n  3. d. Participants with Lymphoplasmacytic lymphoma must have the presence of serum IgM that is at least 2 times the upper limit of normal.\n\n  3\\. CD22 expression, at any level: Participants must have archival tissue available for analysis of CD22 expression or must be willing to undergo biopsy of easily accessible disease.\n\n  4\\. Participants who have progressed or relapsed after prior autologous OR allogeneic SCT must be at least 100 days post-transplant, have no evidence of GVHD, and have been without immunosuppressive drugs at least 30 days.\n\n  5\\. Meet required prior therapy washout windows prior to leukapheresis (see inclusion criteria for leukapheresis for details).\n\n  6\\. Participants with prior CAR therapy must be at least 30 days post CAR infusion and have \\\u003C 5% CD3+ cells express the previous CAR prior to apheresis, if a validated assay is available.\n\n  7\\. Toxicities from prior therapy stable or resolved (except for clinically non-significant toxicity and cytopenias covered in footnote).\n\n  8\\. Age ≥ 18 years of age. 9. Adequate performance status (ECOG 0, 1, or 2; or Karnofsky \\> 60%) 10. Adequate organ and marrow function as defined by:\n\n  \\- ANC ≥ 750\u002FuL\n  * Platelet count ≥ 50,000\u002FuL\n  * ALC ≥ 150\u002FuL\n  * Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine \\\u003C 2 mg\u002FdL OR Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 45 mL\u002Fmin, Serum ALT or AST ≤ 10 x ULN (except in participants with liver involvement by lymphoma), Total bilirubin ≤ 1.5 mg\u002Fdl, except in participants with Gilbert's syndrome, Cardiac left ventricular ejection fraction ≥ 45%, no evidence of clinically significant pericardial effusion as determined by an Echocardiogram.\n  * No clinically significant pleural effusion or ascites\n  * Baseline oxygen saturation \\> 92% on room air ANC Platelet ALC Cr CreatCl AST\u002FALT Bilirubin LVEF O2 Sat\n  * 11\\. Participants with CNS involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity 12. Females of childbearing potential must have negative pregnancy test. 13. Females of child-bearing potential and males of child-fathering potential must be willing to practice birth control from time of enrollment and for 4 months post preparative lymphodepletion regimen or as long as CAR cells are detectable.\n\n    14\\. Must be able to provide informed consent (LAR is permitted if participant able to provide verbal assent).\n\nA participant will not be excluded because of pancytopenia ≥ Grade 3 if it is felt by the investigator to be due to underlying disease.\n\nExclusion Criteria:\n\n* Presence rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.\n\n  2\\. History or current other malignancies, apart from non-melanoma skin cancer, low-grade untreated prostate cancer under observation, or carcinoma in situ, unless disease free for at least 3 years, or in remission 1-2 years and Principal Investigator assesses other malignancy as unlikely to return within 1 year or interfere with CAR T cell safety\n\n  3\\. Presence of active fungal, bacterial, viral or other infection requiring intravenous antimicrobials. Simple UTI or uncomplicated bacterial pharyngitis is permitted if responding to active treatment.\n\n  4\\. Ongoing HIV, HBV, or HCV infection. History of HBV or HCV is permitted if viral load is undetectable by qPCR and\u002For nucleic acid testing.\n\n  5\\. Active cerebrovascular ischemic\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in investigator's judgement impair ability to evaluate neurotoxicity.\n\n  6\\. History of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.\n\n  7\\. Severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.\n\n  8\\. Is pregnant or breastfeeding.\n\n  9\\. Active primary immunodeficiency or history of autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n\n  10\\. May NOT, in investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, or be likely to complete all protocol-required visits and procedures.",{"count":156,"type":21},148,[52],"This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed \u002F refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.",[28,57,160,161,162,60,163,164],"Hairy Cell Leukemia","Lymphoplasmacytic Lymphoma","Burkitt Lymphoma","Waldenstrom Macroglobulinemia","Large B-cell Lymphoma",[166,167,168,169,170,171],"lymphoma","leukemia","lymphodepleting chemotherapy","relapsed","refractory","systemic therapy",{"date":140,"type":33},{"date":174,"type":33},"2024-03-29",{"date":176,"type":21},"2031-04",{"name":178,"class":124},"Stanford University",{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100469168","a-study-of-mosunetuzumab-alone-or-with-zanubrutinib-in-people-with-follicular-lymphoma-100469168","NCT05389293","A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma","An Open-Label, Multicenter, Single-Arm, Sequential Phase-2 Study of Mosunetuzumab Alone or With Zanubrutinib for the Treatment of Patients With Newly Diagnosed Follicular Lymphoma in Need of Systemic Therapy","Inclusion Criteria:\n\n* Signed Informed Consent Form(s)\n* Ability to comply with all the study-related procedures, in the investigator's judgement\n* Age 18 years or older\n* ECOG performance Status of 0, 1, or 2 \\[Appendix 2\\]\n* Untreated histologically documented FL of grade 1, 2, or 3A\n* Stage II bulky (noncontiguous), III, or IV bulky or high burden disease \\[Appendix 3\\]\n* Need of systemic therapy as evidenced by at least one of the following criteria \\[also see Appendix 4\\]:\n\n  * Bulky disease defined as:\n  * Nodal or extranodal mass \\> 7cm in maximum diameter\n  * ≥ 3 nodal or extranodal sites each with a diameter ≥ 3 cm\n  * Presence of any of the following constitutional symptoms:\n  * Fever (\\>38C) of unclear etiology\n  * Night sweats\n  * Weight loss \\>10% within the prior 6 months\n  * Symptomatic splenomegaly\n  * Mass-related symptoms\n  * End-organ damage (e.g., elevated creatinine or elevated liver enzymes) that is clearly related to lymphomatous infiltration in the opinion of the investigator\n  * Any one of the following cytopenias due to lymphoma:\n  * Hemoglobin \\< 10g\u002FdL\n  * Platelets \\<100 x 10\\^9\u002FL\n  * Absolute neutrophil count (ANC) \\< 1.5 x 10\\^9\u002FL\n  * Pleural or peritoneal serous effusion (irrespective of cell content)\n  * Patients with absolute lymphocytosis ≥5,000 cells\u002FµL in the peripheral blood may be allowed to participate after discussion with the study PI\n* Must be considered as a potential candidate for chemoimmunotherapy in the judgement of the treating physician\n* Must have at least one bi-dimensionally measurable lesion (\\>1.5 cm in its largest dimension for nodal lesions, or \\>1.0 cm in its largest dimension for extranodal lesions by computerized tomography \\[CT\\] scan or MRI)\n* Agreement to provide tumor samples as follows:\n\n  * Agreement to undergo biopsy of a safely accessible tumor site per investigator determination prior to the first dose of mosunetuzumab.\n  * Agreement to undergo repeat biopsy of the same tumor site, if safely accessible, or a different safely accessible tumor site, per investigator determination, 14 to 21 days after the first dose of mosunetuzumab.\n  * Patients who are unable or unwilling to undergo either biopsy procedure may be allowed to participate in, or continue with, the study without any penalization after confirmation from the PI. Inability to undergo a new pre-treatment or an on-treatment biopsy are not considered protocol violations.\n* Adequate hepatic function as follows: aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤3 x upper limit of normal (ULN); total bilirubin level ≤1.5 x ULN (except with documented history of Gilbert syndrome)\n* Adequate bone marrow function as follows:\n\n  * Platelet count ≥75 x 10\\^9\u002FL without transfusion within 14 days prior to first dose of mosunetuzumab;\n  * ANC ≥1 x 10\\^9\u002FL\n  * Hemoglobin level ≥9 g\u002FdL without transfusion within 14 days prior to the first dose of mosunetuzumab\n  * Patients who do not meet criteria for bone marrow function due to marrow involvement of lymphoma and\u002For other disease-related cytopenias (e.g., immune thrombocytopenia) may be enrolled into the study after discussion with, and confirmation by the PI.\n* Serum creatinine ≤ULN or estimated creatinine clearance ≥ 45 mL\u002Fmin by Cockcroft-Gault method \\[see Appendix 5\\] or other institutional standard methods (e.g., based on nuclear medicine renal scan)\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of ≤1% per year, and agreement to refrain from donating eggs, during the treatment period and for at least 3 months after the last dose of mosunetuzumab, and 3 months after the last dose of tocilizumab (if applicable), whichever is longer.\n\n  * A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a post-menopausal state (≥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 ≤1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.Hormonal contraception methods must be supplemented by a barrier method.\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 post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse), or use a condom, and agreement to refrain from donating sperm, as defined below:\n\n  * With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 60 days after the last dose of mosunetuzumab and tocilizumab (if applicable) to avoid exposing the embryo. Men must refrain from donating sperm during this same period.\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 and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Inability to comply with all the study-related procedures, in the investigator's judgement.\n* FL grade 3B or transformed FL\n* Patients not meeting criteria for systemic therapy as outlined in section 6.1 and Appendix 4\n* Patients unfit for chemoimmunotherapy for reasons including, but not limited to, advanced age and medical comorbidities\n* FL presenting with isolated extra-nodal localizations, such as duodenal FL, cutaneous FL or FL of the testis\n* Pediatric FL\n* Prior anti-lymphoma therapy\n* Prior solid organ transplantation\n* Prior allogeneic stem cell transplantation within 5 years of FL diagnosis. Previously transplanted patients must be off all GVHD-related prophylaxis in order to be considered eligible.\n* Current or prior central nervous system (CNS) lymphoma\n* Current or past history of significant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n\n  * Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed\n  * Patients with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed\n* Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease \\[see Appendix 6\\], myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina\n* Significant active pulmonary disease (e.g., bronchospasm or obstructive pulmonary 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 4 weeks prior to first mosunetuzumab administration\n* Known or suspected chronic active Epstein-Barr Virus infection\n* Serologic or PCR test results indicating acute or chronic HBV infection\n\n  ° Patients whose HBV infection status cannot be determined by serologic test results (www.cdc.gov\u002Fhepatitis\u002Fhbv\u002Fpdfs\u002Fserologicchartv8.pdf) must be negative for HBV by PCR to be eligible for study participation.\n* Acute or chronic HCV infection\n\n  ° Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation.\n* Serologic test results indicating HIV infection\n* Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study\n\n  * Patients must not receive live, attenuated vaccines (e.g., FluMist®) while receiving study treatment or after the last dose until B-cell recovery to the normal ranges. Killed vaccines or toxoids should be given at least 4 weeks prior to the first dose of study treatment to allow development of sufficient immunity.\n  * Inactivated influenza vaccination during influenza season and the COVID-19 vaccination at any time are allowed. Please see section 10.3.2 (permitted concomitant therapy) for additional guidance on SARS-CoV-2 vaccine administration and timing\n  * Investigators should review the vaccination status of potential study patients being considered for this study and follow the U.S. Centers for Disease Control and Prevention guidelines for adult vaccination with any other non-live vaccines intended to prevent infectious diseases prior to study.\n* Pregnant, lactating, or intending to become pregnant during the study or within 3 months after the last dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable)\n\n  ° Women who are not postmenopausal (≥12 months of non-therapy-induced amenorrhea) or surgically sterile (removal of ovaries and\u002For uterus) must have a negative serum pregnancy test result within 14 days prior to initiation of study drug. If a serum pregnancy test has not been performed within 14 days prior to receiving first study treatment, a negative urine pregnancy test result (performed within 7 days prior to study treatment) must be available.\n* Radiation therapy, unless utilized for the sole purpose of acutely controlling symptomatic disease during the screening period. In this case, at least 2 weeks should lapse between the last radiation dose and the first mosunetuzumab administration and the patient must still have measurable disease outside the field of radiation prior to initiation of the study drug\n* Recent major surgery within 4 weeks prior to first mosunetuzumab administration, except protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)\n* History of autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n\n  * Patients with a remote history of, or well-controlled autoimmune disease, may be eligible to enroll after discussion with and confirmation by the PI.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.\n  * Patients with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible for this study.\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n  * Rash must cover \\<10% of body surface area\n  * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n  * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months.\n* History of known HLH or suspected HLH in the opinion of the investigator\n* History of confirmed progressive multifocal leukoencephalopathy (PML)\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n* History of other malignancy, except:\n\n  * Curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, in situ cervical carcinoma, in situ prostatic neoplasia.\n  * A malignancy treated with curative intent and in remission for at least 2 years prior to the first mosunetuzumab administration\n* Receipt of systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment ≤10 mg\u002Fday prednisone or equivalent within 2 weeks prior to first dose of mosunetuzumab. The following is permitted:\n\n  * The use of up to 12 mg\u002Fday dexamethasone for up to 3 days as antiemetic therapy\n  * The use of up to 1mg\u002Fkg of prednisone or equivalent for ≤7 days to control B symptoms\n  * The use of inhaled corticosteroids\n  * The use of mineralocorticoids for management of orthostatic hypotension\n  * The use of physiologic doses of corticosteroids for management of adrenal insufficiency\n  * The use of premedication corticosteroids prior to undergoing contrast-enhanced imaging studies, in patients who are allergic to contrast agents\n* History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or PI's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results\n\nCohort 2 only:\n\n* Requirement fors ongoing treatment with a strong CYP3A inhibitor or inducer (see section 15.2.3.2)\n* History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.\n* History of intracranial hemorrhage ≤ 180 days before the first dose of study treatment\n* Inability to swallow capsules clinically significant or gastrointestinal dysfunction such as demonstrated malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery, symptomatic inflammatory bowel disease, or bowel obstruction.\n* Consumption of one or more of the following within 3 days prior to the first dose of zanubrutinib:\n\n  * Grapefruit or grapefruit products\n  * Seville oranges, including marmalade containing Seville oranges\n  * Star fruit (carambola)",{"count":187,"type":21},152,[24],"The purpose of this study is to find out if mosunetuzumab is an effective treatment in people with follicular lymphoma that was recently diagnosed and have not yet received any treatments for their disease.",[28,191],"Lymphoma",[193,28,191,194,195],"Mosunetuzumab","Memorial Sloan Kettering Cancer Center","22-100","2026-08-07",{"date":138,"type":33},{"date":199,"type":33},"2022-05-27",{"date":201,"type":21},"2027-12",{"name":194,"class":124},9,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":229},"100607645","phase-2-a-phase-2-multicenter-open-label-trial-to-evaluate-efficacy-and-safety-of-subcutaneous-sc-mosunetuzumab-in-previously-untreated-low-tumor-burden-follicular-lymphoma-ltb-fl-100607645","NCT07191249","Trial to Evaluate Efficacy and Safety of Subcutaneous Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma .","A Phase 2, Multicenter, Open-Label Trial to Evaluate Efficacy and Safety of Subcutaneous (SC) Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma (LTB-FL).","SUNFLOW","Inclusion Criteria:\n\n* at least 18 years old\n* Histologically confirmed classic FL (cFL) (according to WHO-HEAM4R classification)\n* Low tumor burden by GELF criteria\n* No prior therapy except surgery or radiotherapy for disease that was previously localized\n* Ann Arbor Stage III or IV disease\n* Bi-dimensionally measurable FDG-avid disease defined by at least one single node or tumor lesion \\> 1.5 cm assessed by CT scan and\u002For clinical examination\n* Adequate hematologic function defined as follows without growth factors or blood product transfusion within 14 days of first dose of study drug administration:\n\n  1. Hemoglobin, without transfusion, 9 g\u002FdL\n  2. ANC 1.0 109\u002FL\n  3. Platelet count 75 109\u002FL;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Patient can understand and sign the Informed Consent Form (ICF), can communicate with the Investigator, can understand and comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* 1\\. An active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) defined by detectable viral DNA in the blood by PCR. Patients with HIV are eligible provided an undetectable viral load and a CD4 count \\> 200 cell\u002Fmcl\n* 2\\. Any of the following laboratory abnormalities:\n\n  1. Total Bilirubin or GGT or AST or ALT \\> 3 X ULN.\n  2. Creatinine Clearance calculated by Cockcroft and Gault Formula \\\u003C 40 ml\u002Fmin\n* Presence or history of CNS involvement by lymphoma\n* 4\\. Prior history of malignancies other than Lymphoma (except for Basal Cell or Squamous Cell Carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 2 years\n* Contraindication to use Mosunetuzumabor known sensitivity or allergy\n* Pregnant or lactating females\n* 7\\. Female patients of childbearing potential who cannot or do not wish to use an effective method of contraception, during the study treatment and for 3 months thereafter",{"count":213,"type":21},40,[24],"This is a multi-center, open-label, interventional clinical trial designed to evaluate the efficacy and safety of subcutaneous (SC) Mosunetuzumab as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTB-FL), defined by the absence of GELF criteria.",[28],[218,193],"Fullicular Lymphoma-Previously Untreated Low Tumor Burden","2026-08-06",{"date":221,"type":33},"2026-08-11",{"date":223,"type":33},"2026-01-05",{"date":225,"type":21},"2030-03-01",{"name":227,"class":228},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",4,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100610381","phase-1-a-study-of-ly4584180-in-adult-participants-with-previously-treated-blood-cancers-100610381","NCT07226843","A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers","NOVA-BCL6-1, A First-in-Human, Multicenter Phase 1a\u002F1b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants With Previously Treated Hematologic Malignancies","Inclusion Criteria:\n\n* Has been treated for the following blood cancers and has received at least 2 prior lines of systemic therapy or not eligible for available therapy:\n\n  * Diffuse large B-cell lymphoma - not otherwise specified\n  * High-grade B-cell lymphoma\n  * Diffuse large B-cell lymphoma - transformed from indolent lymphomas\n  * Follicular large B-cell lymphoma\n  * Follicular lymphoma\n  * Other non-Hodgkin lymphoma\n* Has measurable disease\n* Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy\n\nExclusion Criteria:\n\n* Has an active second cancer\n* Has known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible and enrolled if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval.\n* Has known Cytomegalovirus infection. Participants with negative status are eligible\n* Has known hepatitis B or C infection or uncontrolled HIV\n* Has known significant heart disease",{"count":238,"type":21},460,[52],"The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it takes the body to eliminate it in patients with previously treated blood cancers. For each participant, the study could last about 9 months or possibly longer including screening.",[242,243,28],"Lymphoma, Non-Hodgkin's","Lymphoma, Diffuse Large B-Cell","2026-08-05",{"date":219,"type":33},{"date":247,"type":33},"2026-04-17",{"date":249,"type":21},"2030-02",{"name":251,"class":40},"Eli Lilly and Company",46,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":266,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":4},"100649685","phase-3-a-study-comparing-a-new-drug-surovatamig-with-standard-radiotherapy-with-or-without-rituximab-in-adults-with-limited-stage-nodal-follicular-lymphoma-100649685","NCT07736950","A Study Comparing a New Drug (Surovatamig) With Standard Radiotherapy With or Without Rituximab in Adults With Limited Stage Nodal Follicular Lymphoma","An ALLG International Randomised Phase III Trial of Surovatamig Versus Involved Site Radiotherapy With or Without Rituximab in Limited Stage Nodal Follicular Lymphoma","RAZOR","Inclusion Criteria:\n\n1. Patients or their legally authorised representative must voluntarily sign and date an informed consent form (ICF), approved by a Human Research Ethics Committee (HREC), prior to the initiation of any screening or trial-specific procedures.\n2. Provide samples for optional genetic research that supports the Genomic Initiative.\n3. Are willing and able to comply with procedures required in this protocol.\n4. Age 18 years and older at the time of signing the informed consent form (ICF).\n5. Must have histologically confirmed classical follicular lymphoma (FL) (previously Grade 1 to 3a FL) at the most recent representative tumour biopsy based on the local pathology report, according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours.\n6. Must have Ann Arbor Stage I or II, nodal, non-bulky disease (maximum tumour diameter less than or equal to 7 cm).\n7. Previously untreated disease (no prior systemic lymphoma-directed therapies).\n8. Has one or more target lesions:\n\n   1. A positron emission tomography\u002Fcomputed tomography (PET\u002FCT) scan demonstrating PET-positive lesion(s), and\n   2. At least one measurable nodal lesion (long axis over 1.5 cm) or at least one measurable extra-nodal lesion (long axis over 1.0 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI).\n9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n10. Patient must have adequate renal and liver function, unless values meeting the following criteria are related to lymphoma:\n\n    1. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less or equal to 3.0 × upper limit of normal (ULN)\n    2. Total bilirubin less or equal to 1.5 × ULN; subjects with Gilbert's syndrome may have total bilirubin greater than 1.5 × ULN, but conjugated (direct) bilirubin must be less or equal to 2 × ULN\n    3. Estimated creatinine clearance (CrCl) greater or equal to 45 mL\u002Fmin (as calculated by the Cockcroft-Gault formula)\n11. Patient must have adequate haematologic function:\n\n    1. Absolute neutrophil count (ANC) greater or equal to 1.0 × 10\\^?\u002FL\n    2. Haemoglobin greater or equal to 8 g\u002FdL\n    3. Platelet count greater or equal to 75 × 10\\^?\u002FL\n12. Patients of child-bearing potential must have a negative serum pregnancy test 10 to 14 days prior to randomisation and again within 24 hours prior to Cycle 1 Day 1 (C1D1). The pregnancy test must be sensitive to at least 25 mIU\u002FmL.\n13. Women of child-bearing potential must agree to practise at least two protocol-specified methods of birth control, effective from 28 days prior to randomisation through at least 12 months after the last dose of trial drug. Female patients of non-child-bearing potential do not need to use birth control.\n14. Male patients who are sexually active with female partners of child-bearing potential must agree, from 28 days prior to randomisation through 12 months after the last dose of trial drug, to practise the protocol-specified contraception, particularly using a latex or synthetic condom every time they have sexual intercourse with a partner of reproductive potential, even if they have undergone a successful vasectomy.\n\nExclusion Criteria:\n\n1. Has a history of prior systemic or radiotherapy therapy for follicular lymphoma (FL).\n2. Has prior or current follicular large B-cell lymphoma (World Health Organization \\[WHO\\] 2022 classification), formerly follicular lymphoma Grade 3B (WHO 2016 classification), histologic transformation to diffuse large B-cell lymphoma (DLBCL) or other aggressive lymphomas.\n3. Known or suspected central nervous system (CNS) involvement at screening based on clinical presentation or imaging findings.\n4. A history of severe allergic or anaphylactic reactions to any component or excipient of AZD486.\n5. Has had major surgery within 14 days prior to the first dose of trial intervention (excluding biopsies) or anticipation of the need for major surgery during trial intervention.\n6. Clinically significant cardiovascular disease, such as:\n\n   1. Myocardial infarction within less or equal to 12 weeks or stroke within 6 months prior to randomisation\n   2. Screening 12-lead electrocardiogram (ECG) showing a baseline QT interval as corrected by Frederica's formula (QTcF) over 480 msec\n   3. The following conditions within 3 months prior to randomisation:\n\n   i. Uncontrolled unstable angina ii. New York Heart Association (NYHA) Class III-IV congestive heart failure iii. Uncontrolled life-threatening cardiac arrhythmia iv. Other clinically significant ECG abnormalities in the opinion of the investigator\n7. History or presence of clinically relevant CNS pathology (based on investigator assessment) such as epilepsy, seizure, paresis, aphasia, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n8. Active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring systemic therapy or antibiotics within 2 weeks prior to randomisation.\n9. Human immunodeficiency virus (HIV) infection unless:\n\n   1. Patients on effective antiretroviral therapy with undetectable viral load within 6 months prior to trial entry are eligible\n   2. HIV ribonucleic acid (RNA) will be monitored during the trial as clinically indicated\n10. Active hepatitis B infection (detectable hepatitis B virus \\[HBV\\] deoxyribonucleic acid (DNA) or hepatitis B surface antigen \\[HBsAg\\]).\n\n    1. Patients who are hepatitis B core antibody \\[HBcAb\\] positive but HBV DNA and HBsAg negative are eligible and will undergo monthly monitoring\n    2. Patients who received intravenous immunoglobulin \\[IVIG\\] may have false-positive HBcAb; if HBV DNA and HBsAg are negative, prophylaxis may be omitted but monitoring is required\n11. Active hepatitis C, defined by detectable hepatitis C RNA in plasma by polymerase chain reaction (PCR). Patients with resolved infection may participate if hepatitis C RNA is undetectable.\n12. Received a live, attenuated vaccine within 28 days prior to initiation of trial treatment.\n\n    a. Patients must not receive live vaccines while receiving trial intervention and for at least 6 months after the last dose of surovatamig or rituximab, and until B-cell recovery is confirmed.\n13. Active tuberculosis (TB) or history of completed treatment for active TB within the past 12 months.\n\n    a. Interferon-gamma release assay (IGRA) testing must be performed if TB is suspected.\n14. History of other prior malignancies, except defined low-risk cases.\n15. Current autoimmune disease requiring immunosuppressive therapy other than prednisolone less than 20 mg daily (or equivalent).\n16. Current seizure disorder requiring therapy (patients with history must have complete CNS workup).\n17. History of clinically significant medical or psychiatric conditions interfering with trial participation or safety.\n18. Participation in another clinical trial with an investigational product within the last 28 days or 5 half-lives.\n19. Female patient who is pregnant, breastfeeding, or planning pregnancy or egg donation during or 12 months after treatment.\n20. Male patients planning to father a child or donate sperm during or 12 months after treatment.",{"count":262,"type":21},138,[25],"The goal of this clinical trial is to learn if surovatamig works better than standard of care involved-site radiotherapy (ISRT) with or without rituximab to treat patients with limited-stage follicular lymphoma. It will also learn about the safety of the drug.\n\nThe main questions it aims to answer is whether surovatamig can produce deeper and more durable responses, reduce the risk of disease relapse, and improve event-free survival.\n\nParticipants will:\n\n1\\) Take surovatamig for 4 cycles. The first cycle will have a dose ramp up in 3 steps over a period of 14 days. Cycle 2-4 are for 28 days with drug administered every fortnight.\n\nOR 2a) Undergo radiotherapy only for 3 weeks OR 2b) Radiotherapy + rituximab weekly for 6 doses (6 weeks)\n\nVisit the clinic once every cycle, at the end of treatment, and be monitored every 3 months in year 1, every 6 months in year 2, and once a year from year 3-5 for checkups and tests.",[28],"NOT_YET_RECRUITING","2026-08-04",{"date":219,"type":33},{"date":270,"type":21},"2027-01-12",{"date":272,"type":21},"2035-01-13",{"name":274,"class":124},"Australasian Leukaemia and Lymphoma Group",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":294,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":304},"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":285,"type":21},32,[52,24],"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.",[289,164,92,93,60,28,57,94,290,162,291,292,293],"B-cell Acute Lymphoblastic Leukemia","High-grade B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[295,296,191],"CD19-positive","Leukemia",{"date":219,"type":33},{"date":299,"type":33},"2025-05-30",{"date":301,"type":21},"2031-09",{"name":303,"class":40},"Vironexis Biotherapeutics Inc.",11,{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":147},"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":314,"type":21},12,[52],"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.",[292,94,28,60,57,162],[319,320,321,322,323,324,325],"CAR-T","Chimeric antigen receptor T-cell therapy","CAR Therapy","Pirtobrutinib","B Cells","BTK inhibitor","Bruton's tyrosine kinase",{"date":219,"type":33},{"date":328,"type":33},"2025-02-06",{"date":330,"type":21},"2030-07",{"name":332,"class":124},"Medical College of Wisconsin",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":342,"phases":4,"briefSummary":343,"conditions":344,"keywords":353,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":147},"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":341,"type":21},200,"OBSERVATIONAL","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)\").",[56,345,346,347,348,349,350,351,28,352],"T-Cell Lymphoma","Diffuse Large B-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",[56,345,94,348,349,352,350,354,28,355,66,356,347,357,358,65,359],"Follicular Lymphoma grade 3B","NHL","HGBCL","PMBCL","PTCL","ALCL","2026-08-03",{"date":219,"type":33},{"date":363,"type":21},"2026-07-27",{"date":365,"type":21},"2032-04",{"name":367,"class":40},"Natera, Inc.",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":379,"conditions":380,"keywords":383,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":403},"100194258","phase-3-a-long-term-extension-study-of-pci-32765-ibrutinib-100194258","NCT01804686","A Long-term Extension Study of PCI-32765 (Ibrutinib)","PCI-32765CAN3001: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study","CAN3001","Inclusion Criteria:\n\n* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib\n* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks\n* Agrees to protocol-defined use of effective contraception\n* Negative blood or urine pregnancy test at screening\n\nExclusion Criteria:\n\n* Requires anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with strong cytochrome P450 (CYP)3A4\u002F5 inhibitors, unless previously approved by sponsor\n* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study",{"count":377,"type":21},700,[25],"The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.",[92,93,57,28,381,163,382],"Diffuse Large B-cell Lymphoma","Chronic Graft Versus Host Disease",[384,385,386,387,388,389,390,391,392,393],"Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Mantle cell lymphoma","Follicular lymphoma","Diffuse large B-cell lymphoma","PCI-32765","Ibrutinib","Bruton's tyrosine kinase inhibitor","IMBRUVICA","JNJ-54179060","2026-07-30",{"date":396,"type":33},"2026-07-31",{"date":398,"type":33},"2013-09-09",{"date":400,"type":21},"2029-12-31",{"name":402,"class":40},"Janssen Research & Development, LLC",175,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":413,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":431},"100467353","phase-1-iks03-in-patients-with-advanced-b-cell-non-hodgkin-lymphomas-100467353","NCT05365659","IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas","A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (NHL)","Inclusion Criteria:\n\n1. Males or females, ≥ 18 years of age\n2. Part I: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible\n3. Part II: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include:\n\n   1. Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)\n   2. Follicular lymphoma (including duodenal-type follicular lymphoma)\n   3. Mantle cell lymphoma\n   4. B cell lymphomas not specified\n4. If B cell NHL subtype likely to have bone marrow involvement must be willing to undergo bone marrow biopsy in the event of an on-study complete response to confirm response\n5. NHL that is relapsed, refractory to, or intolerant of existing therapy(ies) with known curative potential, or for which no standard therapy is available; must have received at least 2 prior lines of systemic therapy\n6. Must be in need of systemic treatment and not require immediate cytoreductive therapy\n7. Part I: measurable or non-measurable disease\n8. Part II: measurable disease according to The Revised Criteria\u002FLugano Classification\n9. Part I: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy\n10. ECOG performance status 0 or 1\n11. Women of childbearing potential and fertile men agreeing to use two effective methods of contraception (including a highly effective method of contraception); women beginning 2 weeks prior to the first dose, men beginning prior to the first dose, and both continuing until 8 months after the last dose of study drug; male patients must also agree to refrain from sperm donation during this period.\n12. Ability to understand and give written informed consent\n\nExclusion Criteria:\n\n1. Women who are pregnant or intending to become pregnant before, during, or within 8 months after the last dose of study drug; women who are breastfeeding\n2. Patients documented to be CD19-negative\n3. Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy; symptoms suggesting CNS involvement\n4. Part 2: History of another malignancy within 2 years, with the exception of:\n\n   1. Treated, non-melanoma skin cancers\n   2. Treated carcinoma in situ (e.g., breast, cervix)\n   3. Controlled, superficial carcinoma of the urinary bladder\n   4. T1a or b prostate carcinoma treated according to standard of care, with PSA within normal limits\n   5. Papillary thyroid carcinoma Stage I treated surgically for cure\n5. Any of the following hematologic abnormalities at baseline (transfusion allowed \\> 5 days previous):\n\n   1. Hemoglobin \\\u003C 8.0 g\u002FdL\n   2. Absolute neutrophil count \\\u003C 1,000 per mm3\n   3. Platelet count \\\u003C 75,000 per mm3\n6. Any of the following laboratory abnormalities at baseline:\n\n   1. Total bilirubin \\> 1.5 × upper limit of normal (ULN); \\> 3 × ULN if with Gilbert's Syndrome\n   2. AST or ALT \\> 3 × ULN; \\> 5 × ULN if due to hepatic involvement by tumor\n   3. Estimated GFR ≤ 60 mL\u002Fmin corrected for BSA\n   4. Albuminuria defined as urine albumin to creatinine ratio \\\u003C 30 mg\u002Fg or \\\u003C 3 mg\u002Fmmol) by spot urine albumin\n7. Any of the following coagulation parameter abnormalities at baseline unless on a stable dose of anticoagulant therapy for a prior thrombotic event:\n\n   1. PT or INR \\> 1.5 × ULN; \\> 3× ULN if anticoagulated)\n   2. PTT \\> 1.5 × ULN; \\> 3× ULN if anticoagulated\n8. Any of the following laboratory abnormalities at baseline aimed at assessing renal function:\n\n   1. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin, corrected for BSA.\n   2. Albuminuria defined as urine albumin to creatinine ratio (UACR) ≥ 45 mg\u002Fg or ≥ 4.5 mg\u002Fmmol by spot urine albumin\n9. Patients with:\n\n   1. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks unless adequately treated and stable\n   2. Active uncontrolled bleeding or a known bleeding diathesis\n10. Significant cardiovascular disease or condition, including:\n\n    1. Congestive heart failure or angina pectoris requiring therapy\n    2. Ventricular arrhythmia requiring therapy or other uncontrolled arrhythmia\n    3. Severe conduction disturbance (e.g., 3rd degree heart block)\n    4. QTc interval ≥ 480 milliseconds\n    5. Left ventricular ejection fraction below the lower limit of normal or \\\u003C 50% by MUGA scan or echocardiogram\n    6. Class III or IV cardiovascular disease according to the New York Heart Association Functional Classification\n    7. History of acute coronary syndromes (e.g., MI, unstable angina), coronary angioplasty, stenting, or bypass within 6 months\n11. Significant liver disease, including:\n\n    1. Non-infectious hepatitis\n    2. Hepatic cirrhosis (Child-Pugh Class B and Class C)\n12. Significant pulmonary disease or condition, including:\n\n    1. Significant symptomatic COPD, as assessed by the Investigator\n    2. History or any current evidence on imaging studies of interstitial lung disease, pulmonary fibrosis\n    3. History of pulmonary inflammatory disease, pneumonitis, ARDS\n    4. History of pneumonia within 1 month\n13. Significant corneal disease or condition, including history of or current evidence of keratitis\n14. Clinically significant CNS disease or condition including PML, epilepsy, vasculitis, or neurodegenerative disease. Also including TIA or stroke within 6 months\n15. Known HIV infection or AIDS\n16. Active hepatitis B virus or hepatitis C virus infection\n17. Any other serious\u002Factive\u002Funcontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \\> 38ºC within 2 weeks\n18. Autoimmune disease or condition requiring systemic steroids or other immunosuppressive medications\n19. Unresolved Grade \\> 1 AE associated with any prior antineoplastic therapy (except persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, neutropenia, lymphopenia, hypomagnesemia, and\u002For endocrine end-organ failure being adequately managed by HRT)\n20. Known or suspected hypersensitivity to any of the excipients of formulated study drug\n21. Inadequate recovery from a surgical procedure, or a major surgical procedure within 4 weeks\n22. Any other serious, life-threatening, or unstable preexisting medical condition, including significant organ system dysfunction, or clinically significant laboratory abnormality(ies)\n23. A psychiatric disorder or altered mental status that would preclude understanding of the informed consent process\n\nDrugs and Other Treatments to be Excluded:\n\n1. Receipt of:\n\n   1. Any CD19-targeted therapy within 4 weeks\n   2. Any tumor vaccine within 6 weeks (must have progressed if previously received)\n2. Prior autologous\u002Fallogeneic CAR-T therapy if known to be CD19-negative after\n3. Any other antineoplastic agent for the primary malignancy without delayed toxicity within 3 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)\n4. Any other investigational treatments within 3 weeks\n5. Drugs known to impair renal function, including:\n\n   1. NSAIDS within 3 days\n   2. Aminoglycoside antibiotics, amphotericin B, etc. within 1 week\n   3. Bisphosphonates within 1 month\n6. Prior solid organ transplant\n7. Allogeneic HSCT within 6 months, or:\n\n   1. If receiving immunosuppression\n   2. If with active evidence of GVHD\n8. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months\n9. Radiotherapy:\n\n   1. To target lesions within 4 weeks unless progression of the lesion has been documented\n   2. To non-target lesions within 1 week\n10. Live\u002Flive-attenuated vaccines against infectious diseases within 4 weeks\n11. Immunosuppressive or systemic glucocorticoid therapy (\\> 10 mg prednisone daily or equivalent) within 2 weeks\n12. Prophylactic use of hematopoietic growth factors within 1 week\n13. Herbal therapies and supplements within 2 weeks\n14. Strong inhibitors of cytochrome P450 within 2 weeks",{"count":412,"type":21},140,[52],"This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).",[416,94,28,57,115],"B-cell Non-Hodgkin Lymphoma",[418,419,355,66,420,421,422,166],"CD19","non-Hodgkin lymphoma","MCL","advance lymphoma","IKS03",{"date":424,"type":33},"2026-07-29",{"date":426,"type":33},"2023-09-05",{"date":428,"type":21},"2028-09",{"name":430,"class":40},"Iksuda Therapeutics Ltd.",13,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":342,"phases":4,"briefSummary":440,"conditions":441,"keywords":442,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":147},"100300427","clonal-evolution-in-follicular-lymphoma-100300427","NCT03190928","Clonal Evolution in Follicular Lymphoma","Prospective Study of Clonal Evolution in Follicular Lymphoma","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed follicular lymphoma (FL), grades 1-2, or 3a confirmed by the Laboratory of Pathology, NCI; patients who meet criteria for immediate initiation of systemic therapy are eligible\n* Adequate tissue available from original diagnostic biopsy.\n\nNOTE: If biopsy was \\>12 months prior to enrollment OR adequate tissue is not available, tissue biopsy may be optionally repeated unless such a biopsy is considered unacceptable risk to the patient. Patients without adequate tissue are eligible at the discretion of the PI.\n\n\\- Must have disease that is measurable or evaluable on either computed tomography (CT) scans or FDG-positron emission tomography (FDG-PET) scans\n\nNOTE: Since patients with FL may have lesions that wax and wane on imaging, the requirement for disease being measurable or evaluable can come from imaging taken at any time at or after diagnosis, the most recent imaging prior to enrollment does not need\n\nto show measurable or evaluable disease.\n\n\\- Age greater than or equal to 18 years\n\nNOTE: Patients with the pediatric-type follicular lymphoma are usually \\\u003C18 years of age, and often have a very different clinical course than patients with the adult-type of FL. Due to this difference in biology, children are excluded from this study.\n\n\\- ECOG performance status \\\u003C2 (Karnofsky \\>60%)\n\nEXCLUSION CRITERIA:\n\n* Previous history of diffuse large B-cell lymphoma or histologic transformation\n* Any prior systemic treatment for lymphoma including cytotoxic chemotherapy, biologic therapy, and monoclonal antibody therapy (radiotherapy permitted); patients who have received chemotherapy, biologic therapy, hormonal therapy, or monoclonal antibody for other malignancies are potentially eligible provided that all of the following are true: a) that malignancy was not lymphoma, b) systemic therapy ended at least 3 years prior to the diagnosis of FL, and c) there is no evidence of active malignancy other than FL\n\nNOTE: Initiation of first-line systemic therapy is allowed while on this trial; concurrent participation in first-line treatment clinical trials will be permitted.\n\n* Patients who are HIV-positive\n* Any second malignancy that requires active systemic therapy\n* Any other (non-lymphoma) life-threatening disease\n* Patients unable to provide informed consent (surrogates will not be used)\n* Pregnant women are excluded from enrollment onto this study because the invasive procedures and\u002For sedation needed to perform them may cause unnecessary harm to the unborn fetus. In the event a woman becomes pregnant while on study, she will not be removed from the study; however, no follow-up invasive clinical or research procedures will be done that include unacceptable to risk to the patient and\u002For to the unborn fetus.",{"count":341,"type":21},"Background:\n\nFollicular lymphoma is a type of cancer of the lymph nodes. Lab studies are important for cancer research. They help scientists better understand differences in the cancer biology of different patients. Researchers want to collect serial samples over time from people with follicular lymphoma to help them design future treatments.\n\nObjective:\n\nTo collect a variety of samples from people with follicular lymphoma to study how these diseases progress and respond to treatment.\n\nEligibility:\n\nAdults at least 18 years old who have been diagnosed with, but have not yet had any treatment for, follicular lymphoma.\n\nDesign:\n\nParticipants will be screened with medical history and physical exam. They will answer questions about daily functioning. They will have blood and urine tests. They may have scans and have tissue samples taken.\n\nParticipants will be monitored about every 4 months for up to 2 years. They will repeat screening tests. They will have a cheek swab. A small brush will be rubbed against the inside of the cheek to wipe off some cells.\n\nParticipants will have imaging scans about every 8 months for up to 2 years.\n\nParticipants may have a bone marrow aspiration and biopsy. The hipbone will be numbed with a small needle.\n\nA needle will be put into the hipbone, and about 2 tablespoons of bone marrow will be taken out through the needle.\n\nParticipants will continue being monitored every 6 months for up to 5 years, then 1 time a year.",[28],[443,444,445,446,447,448],"Disease Monitoring","Molecular Monitoring","Novel Biomarker Identification","Gene Expression Analyses","Watchful-Waiting","Natural History","2026-07-22",{"date":451,"type":33},"2026-07-23",{"date":453,"type":33},"2017-07-27",{"date":455,"type":21},"2029-01-01",{"name":457,"class":458},"National Cancer Institute (NCI)","NIH",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":473,"overallStatus":266,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":482,"locationsCount":484},"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":467,"type":21},15,[52],"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.",[292,471,94,290,472,28,92,93,60,57],"B-cell Non Hodgkin Lymphoma","Primary Mediastinal Large B Cell Lymphoma",[474,475],"NK cells","Natural Killer cells","2026-07-06",{"date":478,"type":33},"2026-07-08",{"date":480,"type":21},"2026-09",{"date":201,"type":21},{"name":483,"class":124},"Paolo Caimi, MD",2,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":512,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":147},"100501157","phase-2-allo-hsct-using-ric-and-ptcy-for-hematological-diseases-100501157","NCT05805605","Allo HSCT Using RIC and PTCy for Hematological Diseases","Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\\\u003C 16 years).\n* 5\u002F6 or 6\u002F6 related donor, OR a 7-8\u002F8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5\u002F10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.\n\nEligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed.\n\nAcute Myeloid Leukemia (AML) and related precursor neoplasms:\n\n2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n\nFavorable risk AML is defined as having one of the following:\n\n* t(8,21) without cKIT mutation\n* inv(16) or t(16;16) without cKIT mutation\n* Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)\n* Normal karyotype with double mutated CEBPA\n* Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n\nAcute lymphoblastic Leukemia (ALL) \u002Flymphoma:\n\nCR2 or greater, CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n\nHigh risk ALL is defined as having one of the following:\n\n* Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n* 30 years of age or older at diagnosis\n* White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n* CNS leukemia involvement during the course of disease\n* Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n* Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.\n\nVery high risk pediatric patients with ALL:\n\npatients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.\n\nBiphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n\nChronic Myelogenous Leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (\\\u003C5% blasts) and with negative MRD by flow cytometry (a positive PCR for BCRABL is acceptable for BMT): Chronic phase patients must have failed at least two different TKIs, been intolerant to all available TKIs or have T315I mutation. Patients with CML blast crisis in CR are only eligible if there is an feasible TKI maintenance plan following BMT.\n\nPlasma Cell Leukemia after initial therapy, who achieved at least a partial remission; or relapsed and achieved subsequent remission (CR\u002FPR) Myelodysplastic Syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \\\u003C 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be \\\u003C 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to \\\u003C5% blasts prior to transplantation Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.\n\nBurkitt's Lymphoma in CR2 or subsequent CR. Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR\u002FPR that has failed or ineligible for an autologous transplantNatural Killer Cell Malignancies. Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for de-bulking chemotherapy before transplant. Patients with refractory disease may be eligible, unless bulky disease and an estimated tumor doubling time of less than one month.\n\nLymphoplasmacytic Lymphoma, Mantle-Cell Lymphomais eligible after initial therapy if chemotherapy sensitive.\n\nLarge Cell and other high risk NHL \\> CR2\u002F\\> PR2: Patients in CR2\u002FPR2 with initial short remission (\\\u003C6 months) are eligible.\n\nRelapsed Multiple Myeloma: that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.\n\nMyeloproliferative Neoplasms\u002FMyelofibrosis - with transfusion dependence or expected survival under 5 years by DIPSS, DIPSS-plus, or MPSS70 calculator.\n\nAcquired Bone Marrow Failure Syndromes except for Fanconi anemia Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nAdditional Criteria for Bulky Disease (lymphomas) if stable disease is best response, the largest residual nodal mass must \\\u003C 5 cm (approximately) If response to previous therapy, the largest residual mass must represent a 50% reduction and be \\\u003C 7.5 cm (approximately)\n\nOrgan Function Criteria\n\nAdequate organ function is defined as:\n\nLiver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis.\n\nRenal: A normal creatinine (adults) or creatinine clearance ≥ 40 mL\u002Fmin (pediatrics). Adults with a creatinine \\> 1.2 mg\u002Fdl or a history of renal dysfunction must have estimated GFR ≥ 40 ml\u002Fmin\u002F1.73m2.\n\nCardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.\n\nPulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.\n\nIf recent confirmed mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Sexually active females of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control during study treatment Voluntary written consent (adult or parent\u002Fguardian with presentation of the minor information sheet, if appropriate)\n\nRelated donors will be evaluated and collected according to UMN BMT program standard processes. Unrelated donors will be identified and collected through the National Marrow and Donor Program (NMDP) per usual steps.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.\n* Untreated active infection\n* Active central nervous system malignancy\n* CML in blast crisis\n* Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.\n* Less than 3 months since prior myeloablative transplant\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.","75 Years",{"count":494,"type":21},56,[24],"This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide\u002F fludarabine\u002Ftotal body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.",[498,499,500,501,502,503,504,505,506,507,162,508,509,93,60,28,510,511],"Acute Myelogenous Leukemia","Acute Lymphocytic Leukemia","Biphenotypic Acute Leukemia","Undifferentiated Leukemia","Prolymphocytic Leukemia","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myelodysplastic Syndromes","Leukemia, Myeloid","Myelodysplastic Syndrome With Excess Blasts-1","Relapsed T-Cell Lymphoma","Relapsed Chronic Lymphocytic Leukemia","Myeloproliferative Neoplasm","Myelofibrosis",[513,514,515,516,517,518,519,520,521,522,523,17],"MDS","CLL","SLL","AML","CML","PFS","TRM","GVHD","MMF","TBI","PTCy","2026-07-02",{"date":476,"type":33},{"date":527,"type":33},"2023-05-01",{"date":529,"type":21},"2028-10-22",{"name":146,"class":124},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":342,"phases":4,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":484},"100324252","evaluation-of-human-immune-responses-vaccination-in-patients-with-lymphoma-100324252","NCT03501576","Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma","Inclusion Criteria:\n\n* Subjects with a diagnosis of lymphoma falling into the following categories:\n\n  * B-NHL who have received 1 cycle of chemotherapy\n  * B-NHL in complete remission and within 12 months after completion of chemotherapy\n  * Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receiving ibrutinib for at least 1 month\n  * B-NHL in complete remission for over 12 months\n  * Aggressive peripheral T-cell lymphoma (PTCL) who have received 1 cycle of chemotherapy\n* Subject capable of providing written or electronic informed consent prior to initiation of any study procedures; subjects able to understand and comply with planned study procedures and be available for all study visits.\n\n  * Screening labs must be within the following ranges or considered to be not clinically significant by the investigator:\n\nHematology:\n\n* Hemoglobin: 7.0-16.1 gm\u002FdL\n* Platelet count: 10-600\u002FµL\n* Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season \\*- Platelet count: 10-600\u002FuL\n\n  * For cohort 1: Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season.\n  * For cohort 3: Subjects must have previously received at least 1 dose of SARS-CoV2 vaccine. Patients who have not receive a prior SARS-CoV2 vaccine will be eligible to enroll in cohort.\n\nExclusion Criteria:\n\n* Known infection with human immunodeficiency virus (HIV). This information will be obtained verbally from the patient\n* Have any medical disease or condition that, in the opinion of the site principal investigator is a contraindication to study participation; this includes any chronic medical condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject?s successful completion of this study\n* Have an acute illness, as determined by the site principal investigator within 72 hours prior to study vaccination; an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol and was not due to an influenza infection\n* Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months\n* Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine\n* Have a history of Guillain-Barre syndrome (GBS)\n* Subjects who had or are suspected to have had an influenza infection in the current influenza season\n* Subjects who, at screening, have abnormal vital signs and\u002For physical exam, including a temperature ≥ 38.0 C, systolic blood pressure ≤ 90 or \\> 180 mmHg, pulse ≤ 60 or \\> 130 beats per minute, new rash, signs of infection\n* Subjects who have already received the seasonal influenza vaccine in the current influenza vaccination season\n* Subjects enrolled in hospice or whose life expectancy is less than 6 months",{"count":341,"type":21},"This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma. Evaluating immune response may increase the understanding of how the immune system changes when patients receive treatment for lymphomas by looking at the antibody levels and the level of the different cells that make up the immune system over time compared to those without lymphoma.",[92,346,28,57,540],"Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma","2026-07-01",{"date":476,"type":33},{"date":544,"type":33},"2018-04-06",{"date":546,"type":21},"2028-05-26",{"name":548,"class":124},"Emory University",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":22,"phases":556,"briefSummary":558,"conditions":559,"keywords":562,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":147},"100582251","combating-cancer-related-fatigue-a-personalized-supportive-care-program-100582251","NCT06860880","Combating Cancer-Related Fatigue: A Personalized Supportive Care Program","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.\n* Significant symptoms of fatigue, as defined by PROMIS Fatigue score \\>50.\n\nExclusion Criteria:\n\n* Other co-existing malignancies.\n* Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.\n* Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia\u002Fthrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.\n* Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention",{"count":213,"type":21},[557],"NA","This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.",[560,191,92,93,28,60,161,163,561],"Indolent Lymphomas","Cutaneous T Cell Lymphoma",[563,564],"exercise","dietary intervention","2026-06-29",{"date":541,"type":33},{"date":568,"type":33},"2025-06-03",{"date":570,"type":21},"2026-12-31",{"name":572,"class":124},"UNC Lineberger Comprehensive Cancer Center",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":604,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":147},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":582,"type":21},300,[24],"This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[586,587,588,191,503,504,589,511,590,591,592,92,93,593,28,161,594,502,595,596,162,597,598,599,600,601,602,603],"Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Myeloproliferative Neoplasms","Myelodysplasia","Refractory Anemia","High Risk Anemia","Marginal Zone B-Cell Lymphoma","Mantle-Cell Lymphoma","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[516,17,513,355,514,517,515],"2026-06-23",{"date":607,"type":33},"2026-06-25",{"date":609,"type":33},"2018-03-30",{"date":611,"type":21},"2028-06-10",{"name":146,"class":124},{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":620,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":22,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":644,"leadSponsor":646,"locationsCount":147},"100590778","evaluation-of-skin-tests-in-biotherapy-allergies-100590778","NCT06971848","Evaluation of Skin Tests in Biotherapy Allergies","ETCABIO","Inclusion Criteria :\n\n* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).\n\nExclusion Criteria:\n\n* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.\n* Poor understanding of the French language\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure",true,{"count":622,"type":21},70,[557],"Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.\n\nThese biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).\n\nUnlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.",[626,627,628,629,630,631,92,28,632,633,634,635,636,637,638,639],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Melanoma Neoplasms","Small Cell Bronchial Carcinomas","Bronchial Carcinoma","Pleural Mesothelioma","Hodgkin's Lymphoma","Myeloma","AL Amyloidosis","Hepatocarcinoma","Colorectal Cancer","Esophageal Squamous Cell Carcinoma","Heart Cancer","Cholangiocarcinoma","Colorectal Adenocarcinoma","2026-06-17",{"date":642,"type":33},"2026-06-18",{"date":640,"type":33},{"date":645,"type":21},"2028-07",{"name":647,"class":228},"University Hospital, Angers",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":22,"phases":657,"briefSummary":658,"conditions":659,"keywords":662,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":664,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":147},"100404393","phase-1-anti-cd19-chimeric-antigen-receptor-t-cells-for-treatment-of-relapsed-or-refractory-non-hodgkin-lymphoma-100404393","NCT04545762","Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma","A Phase 1 Clinical Trial of Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma","THE DOSE ESCALATION COHORT IS CLOSED TO FURTHER ENROLLMENT.\n\nInclusion Criteria:\n\nDose expansion Cohorts:\n\nCohort B (Burkitt):\n\n1. Participants must have a diagnosis of relapsed or refractory Burkitt Lymphoma\n\n   * Participants with Burkitt lymphoma must have relapsed or failed to respond to at least 1 prior line of multiagent chemoimmunotherapy with prior exposure to both an anti-CD20 antibody agent and an anthracycline.\n   * No significant circulating disease, defined as an elevated total lymphocyte count above the upper limit of normal (ULN) due to the presence of malignant cells.\n2. Participants must have measurable disease as defined below:\n\n   * Participants with Burkitt Lymphoma must have Positron Emission Tomography (PET)-positive disease according to \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\"\n\nCohort M\u002FW (Marginal\u002FWaldenström):\n\n1. Participants must have a diagnosis of relapsed or refractory Marginal Zone Lymphoma (MZL), or Lymphoplasmacytic Lymphoma (LPL)\u002FWaldenström Macroglobulinemia (WM):\n\n   o Participants with indolent lymphomas (nodal or extranodal marginal zone lymphoma, and lymphoplasmacytic lymphoma) must have relapsed after or have been refractory to ≥ 2 prior lines of multi-agent chemoimmunotherapy including prior exposure to an anti-CD20 antibody and an alkylating agent.\n2. Participants must have measurable disease as defined below:\n\n   o Participants with Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma\u002FWaldenström Macroglobulinemia: must either have PET-positive disease according to \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\" or serum monoclonal immunoglobulin M (IgM) paraprotein \\> 0.5 g\u002FdL.\n3. Participants with indolent lymphoma (Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma\u002FWaldenström Macroglobulinemia) must have symptomatic disease or steady progression necessitating systemic treatment per investigator discretion.\n\nIn addition, all participants must meet the following criteria:\n\n1. CD19-positive by either immunohistochemistry or flow cytometry analysis on any biopsy. If prior anti-CD19 therapy has been administered, CD19-positivity has to be re-established on the most recent biopsy.\n2. Age ≥18 years at the time of consent.\n3. Absolute lymphocyte count \\> 100\u002FUL.\n4. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2.\n5. Adequate organ function, defined as:\n\n   1. Adequate bone marrow function for apheresis and lymphodepleting chemotherapy\n   2. Hemoglobin \\>8 gm\u002Fdl (transfusions allowed)\n   3. Platelets \\>50,000\u002FuL (transfusions allowed)\n   4. Absolute Neutrophil Count (ANC) \\> 500\u002FuL\n   5. alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\\u003C 3 x institutional upper limit of normal (ULN) and Total bilirubin \\\u003C 1.5 mg\u002Fdl x institutional ULN, except with Gilbert's syndrome\n   6. Serum Creatinine \\\u003C 2 x the institutional ULN\n   7. Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\> 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) within 3 months of screening. Repeat testing may occur at Investigator's discretion.\n6. Adequate vascular access for leukapheresis procedure (either peripheral line or surgically placed line).\n7. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have a negative serum or urine pregnancy test AND agree to use highly effective methods of contraception for 1 year after the last dose of anti-CD19 CAR-T cells.\n8. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method.\n9. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Autologous transplant within 6 weeks of planned CAR-T cell infusion.\n2. Recipient of prior CAR-T cell therapy targeting CD19 outside of this protocol.\n3. Active other malignancy, other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, or breast).\n4. Human immunodeficiency virus (HIV) seropositivity.\n5. 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.)\n6. Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. NOTE: Women of childbearing potential must have a negative serum or urine pregnancy test.\n8. Participants with history of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n9. History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.\n10. Body weight \\\u003C40 kilograms(kg).\n\nEligibility for Infusion of Investigational Product:\n\nParticipants will undergo an evaluation of eligibility on day 1 prior to infusion of anti-CD19 CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions:\n\n1. No significant laboratory abnormalities. Laboratory result abnormalities that are considered not clinically significant by the principal investigator AND are not the result of a demonstrated active infection or an active central nervous system condition.\n2. ECOG performance status \\\u003C 2\n3. No evidence of uncontrolled intercurrent illness including, but not limited to ongoing or active infection, inflammatory response, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations.\n4. No new neurologic symptoms suggestive of an active central nervous system condition, or uncontrolled CNS involvement by lymphoma.\n5. No corticosteroid use within 7 days prior to infusion (with exception of agents used for prevention of emesis during lymphodepletive chemotherapy).",{"count":656,"type":21},36,[52],"This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19).",[660,162,57,28,161,472,94,93,661,56],"Refractory Non-Hodgkin Lymphoma","Transformed Lymphoma",[663],"CAR-T Therapy",{"date":35,"type":33},{"date":666,"type":33},"2020-09-11",{"date":668,"type":21},"2026-10-31",{"name":670,"class":124},"C. Babis Andreadis",{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":4,"eligibilityCriteria":677,"healthyVolunteers":620,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":678,"targetDuration":4,"studyType":22,"phases":680,"briefSummary":682,"conditions":683,"keywords":685,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":147},"100564976","early-phase-1-64cu-llp2a-for-imaging-hematologic-malignancies-100564976","NCT06636175","64Cu-LLP2A for Imaging Hematologic Malignancies","Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B","Inclusion Criteria Healthy Volunteer:\n\n* Adult 18 years of age or older\n* Able to give informed consent.\n* Able to comprehend and willing to follow instructions for study procedures as called for by the protocol\n* Capable of lying still and supine within the PET\u002FCT scanner for up to 75 minutes.\n* No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms.\n* No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions.\n* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.\n\nInclusion Criteria Hematological Malignancy:\n\n* Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease:\n\n  * Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria\n  * Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma\u002Fchronic lymphocytic leukemia\n* Adult 18 years of age or older and able to provide informed consent\n* Capable of lying still and supine within the PET\u002FCT scanner for up to 75 minutes.\n* No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions\n* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative\n* Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate",{"count":679,"type":21},42,[681],"EARLY_PHASE1","This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.",[598,684,28,60,161,93,92],"Low-Grade Lymphoma",[686,687],"PET","Imaging","2026-06-15",{"date":640,"type":33},{"date":691,"type":33},"2025-03-20",{"date":693,"type":21},"2027-03-31",{"name":695,"class":124},"Washington University School of Medicine",{"id":697,"slug":698,"hasResults":12,"nctId":699,"briefTitle":700,"officialTitle":700,"acronym":4,"eligibilityCriteria":701,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":702,"phases":4,"briefSummary":703,"conditions":704,"keywords":4,"overallStatus":705,"whyStopped":4,"lastUpdateSubmitDate":706,"lastUpdatePostDateStruct":707,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":709,"locationsCount":711},"100498892","expanded-access-study-for-the-treatment-of-patients-with-commercially-out-of-specification-axicabtagene-ciloleucel-100498892","NCT05776160","Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel","Inclusion Criteria:\n\n* Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)\n* Deemed medically fit and stable to receive the product per the investigator's evaluation\n* Repeat leukapheresis is not feasible per the investigator's assessment\n* Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release\n* In the investigator's opinion, there is no satisfactory alternative therapy available to the individual\n\nExclusion Criteria:\n\n* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel\n* Uncontrolled active infection or inflammation per physician assessment\n* Primary central nervous system lymphoma","EXPANDED_ACCESS","The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.",[164,28],"AVAILABLE","2026-06-11",{"date":708,"type":33},"2026-06-12",{"name":710,"class":40},"Kite, A Gilead Company",128]