[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-large-b-cell-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,135,0,25,[9,43,66,91,110,133,160,189,201,235,267,294,314,339,365,394,420,467,493,514,537,570,594,629,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054283","phase-3-a-study-to-evaluate-zilovertamab-vedotin-mk-2140-combination-with-rituximab-plus-cyclophosphamide-doxorubicin-and-prednisone-r-chp-versus-rituximab-plus-cyclophosphamide-doxorubicin-vincristine-and-prednisone-r-chop-in-participants-with-previously-untreated-dlbcl-mk-2140-010-100054283",false,"NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant","ALL","18 Years",{"count":20,"type":21},1046,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[27],"Diffuse Large B-Cell Lymphoma",[29],"Lymphoma, Large B-Cell, Diffuse","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2025-01-27",{"date":38,"type":21},"2032-03-29",{"name":40,"class":41},"Merck Sharp & Dohme LLC","INDUSTRY",266,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100608347","an-observational-study-of-glofitamab-in-chinese-adult-participants-with-2l-diffuse-large-b-cell-lymphoma-100608347","NCT07200375","An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma","Evaluating Effectiveness and Safety of Glofitamab Based Second-Line Therapy in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Cohort Study","GlofitReal","Inclusion Criteria:\n\n* Histologically confirmed R\u002FR DLBCL after one line of systemic therapy\n* Will be treated with Glofit-based regimen (known as being recommended and having the intention to be treated with Glofitamab at the time of signing ICF) or have initiated Glofit-based regimen treatment within three months (90 days) prior to enrollment\n\nExclusion Criteria:\n\n* Participants who currently participate in or plan to participate in any interventional clinical trial",{"count":52,"type":21},300,"OBSERVATIONAL","This study will investigate how well glofitamab-based therapy works and how safe it is in Chinese adult participants with relapsed or refractory diffuse large B-cell lymphoma (R\u002FR DLBCL).",[27],"2026-07-01",{"date":58,"type":34},"2026-07-02",{"date":60,"type":34},"2025-09-29",{"date":62,"type":21},"2029-09-29",{"name":64,"class":41},"Hoffmann-La Roche",19,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100533531","phase-1-pilot-study-of-anti-cd19-chimeric-antigen-receptor-t-cells-car-t-cells-for-the-treatment-of-relapsedrefractory-cd19-malignancies-100533531","NCT06227026","Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed\u002FRefractory CD19+ Malignancies","PRODIGY","Inclusion Criteria:\n\n* Subjects aged ≥ 18 years.\n* Histologically confirmed relapsed or refractory CD-19+ malignancy, including: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)\u002FRichter's syndrome. CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis.\n* Subjects who have relapsed or refractory disease after failing at least 2 or more prior lines of therapy.\n* ECOG Performance Status ≤ 2.\n* Life expectancy \\> 12 weeks.\n* Willing to consent to 15 years of follow-up as part of IRB 110692: Long-Term Evaluation of the Biology and Outcomes of Hematopoietic Stem Cell Transplantation\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 500\u002Fmm3\n    * Platelet count ≥ 10,000\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002FdL\n  * Hepatic:\n\n    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN).\n    * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n  * Renal:\n\n    * Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \\>30 ml\u002Fmin\u002F1.73m2\n* For subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Subjects \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Subjects ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago\n* Subjects of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.\n* Recovery to baseline or ≤ Grade 2 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered stable by the treating investigator.\n* Adequate venous access.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Step 2 Eligibility Confirmation\n\n  * The following criteria must be confirmed within 7 days prior to lymphodepletion. If all criteria are not met, lymphodepletion should be delayed.\n\n    * Confirmation of successful CAR-T manufacturing.\n    * No evidence or suspicion of an infection.\n    * Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \\>30 ml\u002Fmin\u002F1.73m2\n    * No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risk from lymphodepleting chemotherapy or exclude them from treatment with study CAR-T therapy.\n* Step 3 Eligibility Confirmation\n\n  * The following criteria must be confirmed prior to CAR-T therapy. If all criteria are not met, CAR-T therapy should be delayed.\n\n    * No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risks from treatment with CAR-T therapy.\n    * Confirmation that washout periods outlined in section 6.6 and Appendix 10 have been followed.\n\nExclusion Criteria:\n\n* Autologous or allogeneic stem cell transplant or CAR-T therapy within 6 weeks of planned CAR-T cell infusion.\n* Subjects with active infection that requires systemic treatment\n* History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of child bearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.\n* Receiving other investigational agents.\n* Confirmation that washout periods listed in Appendix 10 have been followed.\n* Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.\n* The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and\u002For will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6). Patients with transformed disease are allowed.\n* Known brain metastases or cranial epidural disease. Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and\u002For surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 500 ms.\n    * Known congenital long QT.\n    * Left ventricular ejection fraction \\\u003C 55%.\n    * Uncontrolled hypertension defined as ≥ 140\u002F90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or seropositive HIV. Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).\n* Subjects taking prohibited medications as described in Section 6.6 and Appendix 10. Unless otherwise stated, a washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.\n* Subjects with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.",{"count":74,"type":21},10,[76],"PHASE1","This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells.\n\nThis study will utilize a staggered enrollment design with a safety observation period.",[79,80],"Acute Lymphoblastic Leukemia","Diffuse Large B Cell Lymphoma","2026-06-30",{"date":58,"type":34},{"date":84,"type":34},"2024-02-20",{"date":86,"type":21},"2027-05",{"name":88,"class":89},"University of Utah","OTHER",1,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":100,"studyType":53,"phases":4,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100512627","a-study-to-evaluate-the-effectiveness-and-safety-of-polatuzumab-in-real-world-clinical-practice-among-adult-chinese-participants-with-diffuse-large-b-cell-lymphoma-100512627","NCT05954910","A Study to Evaluate the Effectiveness and Safety of Polatuzumab in Real World Clinical Practice Among Adult Chinese Participants With Diffuse Large B-Cell Lymphoma","The Effectiveness and Safety of Polatuzumab in Real-World Clinical Practice Among Chinese Adult Patients With Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Registry Study","Inclusion Criteria:\n\n* Be diagnosed as DLBCL\n* Cohort 1: diagnosed as unfit\u002Ffrail DLBCL. The unfit\u002Ffrail is defined as aged 80 years or older, or younger than 80 years but with comorbidity and not tolerant to the standardized dose of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy according to investigator's judgment\n* Cohort 2: diagnosis as DLBCL but could not be classified into unfit\u002Ffrail\n* Cohort 3: relapse or refractory to previous treatment\n\nExclusion Criteria:\n\n* Participant who currently participates in or with plan to participate in any interventional clinical trial\n* Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.",{"count":99,"type":21},1000,"3 Years","The purpose of this study is to assess the progression free survival (PFS) in the real-world settings of polatuzumab among Chinese diffuse large B cell lymphoma (DLBCL) participants.",[27],{"date":56,"type":34},{"date":105,"type":34},"2023-08-25",{"date":107,"type":21},"2027-05-31",{"name":64,"class":41},29,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100587533","phase-3-a-phase-3-clinical-study-of-shr-a1912-combined-with-r-gemox-versus-r-gemox-in-diffuse-large-b-cell-lymphoma-100587533","NCT06929624","A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma","A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).\n2. Have received ≥1 line of systemic antitumor therapy.\n3. At least one bi-dimensionally measurable lesion.\n4. Expected survival of at least 3 months.\n5. Age ≥18 years old and under 80 years old.\n6. The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Central nervous system lymphoma involvement.\n2. Primary mediastinal (thymus) large B-cell lymphoma.\n3. Patients who have only one prior line therapy and are candidates for stem cell transplantation.\n4. A history of immunodeficiency.\n5. A history of severe cardiovascular disease.\n6. A history of other malignancies within 5 years prior to administration of the first dose.","80 Years",{"count":119,"type":21},280,[24],"This is a multicenter, randomized, open-label, phase 3 clinical study to evaluate the efficacy of SHR-A1912 combined with R-GemOx in relapsed refractory diffuse large B-cell lymphoma.",[123],"Diffuse Large B-cell Lymphoma","2026-06-29",{"date":56,"type":34},{"date":127,"type":34},"2025-04-24",{"date":129,"type":21},"2028-01",{"name":131,"class":41},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",2,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100512405","phase-2-study-of-acalabrutinib-and-rituximab-in-untreated-elderly-andor-frail-patients-with-dlbcl-100512405","NCT05952024","Study of Acalabrutinib and Rituximab in Untreated Elderly and\u002For Frail Patients With DLBCL","A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and\u002For Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE)","ACRUE","Inclusion Criteria:\n\n* ≥ 80 years of age at the time of screening, or\n* ≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy\n* Histologically documented DLBCL\n* No prior treatment for DLBCL\n* Stage II, III, or IV disease by the Ann Arbor Classification .\n* Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma.\n* At least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements.\n* Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening.\n\nExclusion Criteria:\n\n* Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol.\n* History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results.\n* Serologic status reflecting active hepatitis B or C infection.\n* Serological positivity or known infection with HIV.\n* Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.\n* Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of \\> 17.\n* History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.\n* Known active significant infection.\n* History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug.\n* History of bleeding diathesis (eg, haemophilia, von Willebrand disease).\n* Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe.\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.\n* Received a live virus vaccination within 28 days of the first dose of study drug.","65 Years","99 Years",{"count":144,"type":21},80,[146],"PHASE2","The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and\u002For frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.",[27],[150,151],"Chemoimmunotherapy treatments","Treatment-naïve elderly patients",{"date":81,"type":34},{"date":154,"type":34},"2024-07-16",{"date":156,"type":21},"2029-04-22",{"name":158,"class":41},"AstraZeneca",57,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":90},"100362726","phase-2-acalabrutinib-with-da-epoch-r-or-r-chop-for-people-with-untreated-diffuse-large-b-cell-lymphoma-100362726","NCT04002947","Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma","A Phase 2 Study of Acalabrutinib With DA-EPOCH-R or R-CHOP for Patients With Untreated Diffuse Large B-cell Lymphoma","-INCLUSION CRITERIA:\n\n1. Patients must have a confirmed histologic diagnosis of an aggressive B-cell lymphoma with morphologic appearance of DLBCL or high-grade B-cell lymphoma (HGBL) confirmed by the Laboratory of Pathology, NCI, with no prior treatment for DLBCL or HGBL. The following subtypes are included:\n\n   * DLBCL, NOS, Activated B-cell type (ABC)\n   * DLBCL, NOS, Germinal center B-cell type (GCB)\n   * T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n   * Primary cutaneous DLBCL, leg-type\n   * EBV+ DLBCL, NOS\n   * DLBCL associated with chronic inflammation\n   * ALK+ large B-cell lymphoma\n   * High-grade B-cell lymphoma, NOS\n   * High-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements\n\n   NOTE: Presence of concomitant indolent lymphomas such as follicular lymphoma, marginal zone lymphomas, monoclonal B-cell lymphocytosis or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma that are best categorized as composite or transformed lymphomas are allowed.\n2. A formalin-fixed tissue block or 15 slide of tumor sample (archival or fresh) must be available for performance of correlative studies.\n\n   NOTE: Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator. Patients must be willing to have a tumor biopsy if adequate archival tissue is not available (i.e., post-enrollment and prior to treatment).\n3. Measurable lymph nodes or masses of at least 1.5 centimeters (cm) on baseline CT or MRI\n4. Stage II, III, or IV disease as classified by the Ann Arbor Classification\n5. Age greater than or equal to 18 years\n6. ECOG performance status less than or equal to 2.\n7. Adequate organ and marrow function as defined below unless dysfunction is felt to be secondary to lymphoma involvement as determined by the treating investigator:\n\n   * absolute neutrophil count\\* \\>=1,000\u002FmcL\n   * hemoglobin\\* \\>= 8 g\u002FdL (transfusions permitted to meet criteria)\n   * Platelets \\>= 75,000\u002FmcL (transfusions not permitted)\n   * total bilirubin \\\u003C= 1.5 X institutional ULN (or \\\u003C= 3 X institutional ULN for patients with documented Gilberts syndrome or cholestatic obstruction or involvement by lymphoma)\n   * AST(SGOT)\u002FALT(SGPT) \\\u003C= 3 X institutional ULN (\\\u003C= 5 x ULN for patients with cholestatic obstruction or involvement by lymphoma\n   * Serum creatinine \\\u003C= 2.0 mg\u002FdL\n\n   OR\n\n   -Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above 2 mg\u002FdL\n\n   \\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n   NOTE: In patients without bone marrow involvement, transfusions of RBCs are permitted to achieve the criterion hemoglobin of 8g\u002Fdl, but transfusions of platelets are not permitted to achieve the criterion platelet count of \\>75,000\u002FmcL. In patients with bone marrow involvement, all transfusions are permissible at the discretion of the investigator.\n8. Effects of acalabrutinib on the developing human fetus are unknown. For these reasons the following measures apply:\n\n   * Individuals of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment.\n   * Individuals of childbearing potential who are sexually active must agree to highly effective contraception prior to study entry, for the duration of study participation, and for at least 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later. Individuals who can father children must use highly effective contraception prior to study entry, for the duration of study participation, and for 12 months after the last dose of combined chemotherapy; there is no contraception timing requirement post-last dose of acalabrutinib alone if an individual who can father children does not initiate chemotherapy on study after the acalabrutinib window.\n   * Participants must not be planning to conceive or father children within the projected duration of the trial, starting with the pre-screening\u002Fscreening visit through 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later.\n\n   NOTE: An individual is considered of childbearing potential, (i.e., fertile), following menarche and until becoming post-menopausal unless permanently sterile or have a congenital or acquired condition that prevents childbearing. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy at least 6 weeks before screening. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. In individuals of childbearing potential \\\u003C45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in individuals of childbearing potential not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient The investigator or a designated associate is requested to advise the subject how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence.\n\n   Individuals who can father children are considered to be of non-reproductive potential if they are permanently sterile due to bilateral orchiectomy.\n\n   Highly effective methods of contraception (to be used during heterosexual activity) are defined as methods that can achieve a failure rate of \\\u003C1% per year when used consistently and correctly. Such methods include:\n   * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal\n   * Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable\n   * Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)\n   * Bilateral tubal occlusion\n   * Vasectomy of participant or participant's partner (with medical assessment and confirmation of vasectomy surgical success)\n   * Sexual abstinence (only if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments)\n\n   Hormonal contraception may be susceptible to interaction with study or other drugs, which may reduce the efficacy of the contraception method.\n\n   Abstinence (relative to heterosexual activity) can only be used as the sole method of contraception if it is consistently employed during the entire period of risk associated with the study treatments.\n\n   Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, and post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n9. Ability of patient to understand and the willingness to sign a written informed consent document.\n10. Any HIV status will be included in this study; status must be confirmed prior to enrollment.\n\nEXCLUSION CRITERIA:\n\n1. Patients who meet histologic criteria for the following subtypes are excluded:\n\n   * Primary DLBCL of the central nervous system (PCNSL)\n   * Primary mediastinal B-cell lymphoma (PMBL)\n   * Plasmablastic lymphoma\n   * Intravascular large B-cell lymphoma\n   * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n2. Patients who, at the discretion of the investigator, need immediate cytoreductive chemotherapy such as patients with evidence of spontaneous tumor lysis or impending organ compromise are not eligible.\n3. Current or prior anti-cancer treatment for DLBCL prior to enrollment. Short course of corticosteroids (\\\u003C7 days) for acute issues prior to study enrollment are permitted.\n4. Major surgical procedure within 30 days of first dose of study drug. If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n5. Requires treatment with moderate or strong CYP3A inhibitors or inducers\n6. Known lymphomatous involvement of the CNS\n7. Pregnant individuals, or individuals who intend to become pregnant during the study are excluded from this study because of potential teratogenic effects associated with acalabrutinib, R-CHOP, and\u002For DA-EPOCH-R\n8. The potential for all study treatments to be excreted in the milk of nursing mothers is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with acalabrutinib, nursing must be discontinued.\n9. Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n   -Other malignancy that requires ongoing systemic hormonal therapy, chemotherapy, or immunotherapy.\n\n   Uncontrolled active systemic infection\n   * Any condition that requires anticoagulation with warfarin or equivalent vitamin K antagonist\n   * Active bleeding, history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)\n   * Suspected or confirmed Progressive Multifocal Leukoencephalopathy (PML)\n   * Active hepatitis C infection. NOTE: Subjects who are hepatitis C antibody positive will need to have a negative HCV PCR result before enrollment. Those with a positive PCR for hepatitis C are excluded.\n   * Active hepatitis B infection. NOTE: Patients who are hepatitis B surface antigen (HbsAg) positive will be excluded from enrollment. Patients who are hepatitis B core antibody (HbcAb) positive will need to have a negative HBV PCR result before enrollment. Those with a positive PCR for hepatitis B are excluded. Those who are hepatitis B core antibody (HbcAb) positive with a negative PCR for hepatitis B will be treated with antivirals designed to prevent hepatitis B reactivation (e.g., entecavir) throughout therapy and for 12 months after therapy and have monitoring for hepatitis B reactivation with PCR.\n   * History of hemorrhagic stroke or intracranial hemorrhage in preceding 6 months\n   * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled atrial fibrillation\u002Fflutter during screening are eligible.\n   * Uncontrolled autoimmune hemolytic anemia\n   * Inability to swallow oral medications, or disease involve that significantly limits absorption of oral medication\n   * Known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n10. Concurrent participation in another therapeutic clinical trial.",{"count":168,"type":21},132,[146],"Background:\n\nDiffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate.\n\nObjective:\n\nTo see if the drug acalabrutinib given with rituximab and standard combination chemotherapy can improve the cure rate of aggressive B-cell lymphomas such as diffuse large B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with an aggressive B-cell lymphomas that have not been treated\n\nDesign:\n\nParticipants will be screened with:\n\nBlood and urine tests\n\nPhysical exam\n\nMedical history\n\nTumor biopsy\n\nBone marrow biopsy: A needle will remove marrow from the participant s hipbone.\n\nLumbar puncture: If necessary, a needle will remove fluid from the participant s spinal canal.\n\nImaging scans\n\nParticipants will take the study drug for up to 14 days. It is a pill taken 2 times a day. Then they will have more scans. They will get rituximab and chemotherapy. They may get these drugs through a needle in an arm vein. Or they may them through a tube placed in a vein in their chest or in their neck. They might also keep taking the study drug. Each treatment cycle lasts 21 days. They will have up to 6 cycles.\n\nParticipants may have 4 doses of another drug injected into their spinal fluid.\n\nParticipants will have repeats of the screening tests throughout the study.\n\nParticipants will have a follow-up visit 30 days after their last treatment, then every 3 months for 2 years, then every 6 months for 3 years, and then yearly.",[172,27,173,174],"Non-Hodgkin's Lymphoma","DLBCL","NHL",[176,177,178,179],"BTK Inhibitor","Calquence","ACP-196","Monoclonal Antibody","2026-06-27",{"date":81,"type":34},{"date":183,"type":34},"2019-08-05",{"date":185,"type":21},"2031-03-31",{"name":187,"class":188},"National Cancer Institute (NCI)","NIH",{"id":190,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":25,"conditions":193,"keywords":194,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":198,"leadSponsor":199,"locationsCount":200},"100571215",{"count":20,"type":21},[24],[27],[29],"2026-06-26",{"date":124,"type":34},{"date":36,"type":34},{"date":38,"type":21},{"name":40,"class":41},263,{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":209,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100502329","phase-3-acalabrutinib-in-combination-with-r-minichop-in-older-adults-with-untreated-diffuse-large-b-cell-lymphoma-100502329","NCT05820841","Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma","A Randomized, Open-label, Phase 3 Study of Acalabrutinib in Combination With Rituximab and Reduced Dose CHOP (R-miniCHOP) in OldEr Adults With Untreated Diffuse Large B-Cell Lymphoma","ARCHED","Inclusion Criteria:\n\nInformed consent\n\n1. Ability to understand the purpose and risks of the study and capable of giving signed informed consent which includes:\n\n   1. Compliance with the requirements and restrictions listed in the informed consent form (ICF).\n   2. Authorization to use protected health information\u002Fdata \\[in accordance with the General Data Protection Regulation (GDPR)\\].\n2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses\n3. Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty.\n\n   Age\u002FSex\n4. Men and women \\>80 years of age or \\>60 up to 80 years of age and ineligible for full dose R-CHOP according to investigator assessment\\*.\n\n   We recommend classifying patients aged 61-80 as full-dose R-CHOP ineligible if they fulfill one of the following criteria: ADL \\\u003C5, IADL \\\u003C6, CIRS-G ≥1 score = 3, or \\> 8 score = 2.\n5. Male patients who are sexually active with women of childbearing potential (definitions see section 17.8) must agree to use highly effective forms of contraception with the addition of a barrier method (condom) during the study (see section 17.8.1) as well as to the restrictions mentioned in section 9.13.\n6. Female patients of childbearing potential (definitions see 17.8) who are sexually active must agree to use highly effective forms of contraception while on the study as well as to the restrictions mentioned in section 9.13.\n\n   Disease characteristics\n7. Histologically proven, previously untreated CD20+ diffuse large B-cell lymphoma (DLBCL) according to the 2017 WHO classification including:\n\n   1. diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)\n   2. primary cutaneous DLBCL leg type\n   3. intravascular large B-cell lymphoma\n   4. EBV+ DLBCL, NOS\n   5. HHV8+DLBCL, NOS\n   6. primary mediastinal (thymic) large B-cell lymphoma\n   7. B-cell lymphoma, with intermediate features between DLBCL and classical Hodgkin lymphoma\n   8. follicular lymphoma grade 3B\n   9. high-grade B-cell lymphoma, NOS\n   10. high-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements\n   11. T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n   12. DLBCL associated with chronic inflammation\n   13. ALK+ large B-cell lymphoma\n   14. large B-cell lymphoma with IRF4 rearrangement Please note: patients in whom indolent lymphoma is diagnosed concurrently with the one of the above listed diagnoses can also be included.\n8. Disease Stage I with bulk ≥7.5cm, II, III or IV according to Ann Arbor Classification Type of patient and clinical characteristics\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. An ECOG Score of 3 is acceptable only if this is directly attributable to lymphoma.\n10. Meet the following laboratory parameters:\n\n    1. Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fµl or platelet count ≥ 100.000\u002Fµl unless directly attributable to lymphoma.\n    2. Serum AST and ALT ≤3 x upper limit of normal (ULN) unless directly attributable to lymphoma.\n    3. Total bilirubin ≤1.5 x ULN, unless directly attributable to Gilbert's syndrome or lymphoma.\n    4. Estimated creatinine clearance of ≥30 mL\u002Fmin, calculated by Cockcroft-Gault (using actual body weight) (if male, \\[140-Age\\] x Mass \\[kg\\] \u002F \\[72 x creatinine mg\u002FdL\\]; multiply by 0.85 if female), or serum creatinine ≤2.5 x ULN.\n\nExclusion Criteria:\n\nMedical conditions\n\n1. Evidence of disease (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension and renal transplant) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol \\[e.g. a single score of 4 on one single category on the CIRS-G-Score (but not a cumulative score of 4)\\].\n2. Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of randomization or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF \\\u003C 40%. Patients with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.\n3. Severe pulmonary dysfunction (CTCAE grade 3 or 4) unless associated with lymphoma.\n4. Severe psychiatric or neurologic disease that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.\n5. Persistent neuropathy CTCAE grade 3 or 4.\n6. Refractory nausea and vomiting, inability to swallow acalabrutinib, or malabsorption syndrome; chronic severe gastrointestinal disease, gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment.\n7. History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following:\n\n   1. Curatively treated localised basal cell carcinoma or localised squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ \u002F low risk carcinoma of the prostate requiring only observation, as well as untreated low grade lymphoma except chronic lymphocytic leukemia.\n   2. Other cancers not specified above that have been curatively treated by surgery and\u002For radiation therapy from which patient is disease-free for ≥2 years (≥5 years for those treated with chemotherapy) without further treatment or which are not expected to limit survival to \\\u003C 2 years.\n8. Received a live virus vaccination within 28 days of randomization.\n9. Known history of infection with HIV.\n10. Any active significant infection (e.g., bacterial, viral or fungal) as assessed by the investigator.\n11. History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML).\n12. Serologic status reflecting active hepatitis B or C infection.\n\n    1. Patients who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before randomization and must be willing to undergo DNA PCR testing during the study. Those who are HBsAg-positive or hepatitis B PCR positive will be excluded.\n    2. Patients who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.\n13. History of stroke or intracranial hemorrhage within 6 months before randomization.\n14. History of clinically relevant bleeding diathesis (e.g., hemophilia, von Willebrand disease).\n15. Major surgical procedure within 30 days before randomization. Note: If a patient had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug.\n16. Breastfeeding or pregnant women.\n17. Current life-threatening illness, medical condition, organ system dysfunction, social, geographical or economic condition which, in the Investigator's opinion, could compromise the patient's safety or put the study at risk.\n18. Diagnosis of primary central nervous system lymphoma or secondary central nervous system or meningeal involvement by lymphoma\n19. Diagnosis of Richter's Transformation\u002Ftransformed CLL Prior\u002FConcomitant therapy\n20. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists. Patients using therapeutic low molecule weight heparin, direct oral anticoagulants or low dose aspirin will be eligible. Switching from vitamin K antagonists to one of the allowed anticoagulants above prior to trial entry is permitted.\n21. Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited. See details in section 9.12.1.\n22. Prior exposure to a BTK inhibitor.\n23. Prior anthracycline use ≥300 mg\u002Fm2.\n24. Already initiated lymphoma therapy except for steroid (max. total dose of 1000mg), vincristine (max. 1 mg once) or rituximab (max. 375mg\u002Fm2) prephase.\n25. Concurrent participation in another therapeutic clinical trial.\n26. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Patients receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrolment into this study.\n27. Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.","61 Years",{"count":211,"type":21},330,[24],"The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib.\n\nParticipants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.",[215,80],"Large B-cell Lymphoma",[217,218,219,220,221,222,223,224,225],"Diffuse large B cell lymphoma","Older adults","Geriatric","Large B cell lymphoma","Aggressive B cell lymphoma","Acalabrutinib","R-miniCHOP","R-mini-CHOP","BTK inhibitor","2026-06-24",{"date":124,"type":34},{"date":229,"type":34},"2023-06-07",{"date":231,"type":21},"2029-02",{"name":233,"class":89},"Universität des Saarlandes",17,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":242,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":266},"100369743","phase-3-study-of-out-of-specification-for-tisagenlecleucel-100369743","NCT04094311","Study of Out of Specification for Tisagenlecleucel","A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication","Key inclusion criteria:\n\n* Signed informed consent\u002Fassent must be obtained for this study prior to participation in the study.\n* Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.\n* Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country\u002Fregion.\n* OOS material has not been deemed to pose an undue safety risk to the patient.\n* Patient is suffering from a serious or life-threatening disease or condition.\n* Repeat leukapheresis is not clinically appropriate per the investigator assessment.\n\nKey exclusion criteria:\n\nFor part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:\n\n* Human immunodeficience virus (HIV) positive patients.\n* Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).\n* Patients with primary central nervous system (CNS) lymphoma.\n* History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.\n* Uncontrolled active infection or inflammation.\n* Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment.\n* Pregnant or nursing (lactating) women. For part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of CTL019.","0 Years","100 Years",{"count":245,"type":21},200,[24],"This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.",[249,123],"B-cell Acute Lymphoblastic Leukemia",[251,252,253,254,255,256,257],"out of specification","tisagenlecleucel","acute lymphoblastic leukemia","large B-cell lymphoma","relapsed\u002Frefractory","pediatric","young adult patients",{"date":259,"type":34},"2026-06-25",{"date":261,"type":34},"2019-11-21",{"date":263,"type":21},"2027-03-31",{"name":265,"class":41},"Novartis Pharmaceuticals",54,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":132},"100591229","phase-1-loncastuximab-and-roflumilast-added-to-r-chop-lo-rituximab-and-roflumilast-rr-chop-for-nave-high-risk-diffuse-large-b-cell-lymphoma-dlbcl-100591229","NCT06977711","Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)","Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Men and women 18 years of age or older.\n2. Pathologically proven diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS).\n\n   \\- Patients with Diffuse large B-cell lymphoma\u002F high grade B-cell lymphoma with MYC (myelocytomatosis oncogene) and BCL2 (B-cell lymphoma 2) rearrangements are allowed.\n3. No prior systemic therapy for lymphoma.\n4. Subject has provided informed consent.\n5. Subject is willing and able to comply with clinic visits and procedure outlined in the study protocol.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n7. Life expectancy of ≥3 months.\n8. Ann Arbor stage II-IV\n9. National Comprehensive Cancer Network - International Prognostic Index (NCCN-IPI) risk score of ≥ 2\n10. Measurable disease, meaning at least 1 lymph node or other lymphomatous lesion with a long axis of ≥1.5 cm by CT imaging, and at least one FDG-avid lesion by FDG-PET scan.\n11. Left ventricular ejection fraction of at least 45% by either echocardiography or radionucleotide angiography.\n12. Ability to swallow oral tablets without difficulty.\n13. All subjects with preserved reproductive potential must agree to practice abstinence or employ contraceptive measures for the duration of treatment and for 10 months (if female) or 7 months (if male) following final dosing. All male subjects are considered to have reproductive potential.\n\n    Female subjects of reproductive potential are those who:\n\n    i) are not at least 50 years old and have no menses for 24 consecutive months; or ii) have not been rendered surgically sterile (having undergone hysterectomy and\u002For bilateral salpingo-oophorectomy).\n\n    Female subjects of reproductive potential must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin (hCG) within 7 days of first day of drug dosing.\n14. Meet the following clinical laboratory requirements:\n\n    * Creatinine clearance ≥30 ml\u002Fmin by Cockcroft-Gault formula;\n    * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis);\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 3 × ULN;\n    * Platelet count ≥ 50,000\u002FµL, with or without transfusion support;\n    * Absolute Neutrophil Count (ANC) ≥ 1000\u002FµL, with or without chronic granulocyte growth factor support;\n    * Hemoglobin ≥8 g\u002FdL, with or without transfusion support.\n\nExclusion Criteria:\n\n1. Allergy or intolerance to roflumilast.\n2. Allergy or intolerance to loncastuximab\n3. Any active malignancy other than DLBCL\n4. Current participation in another interventional clinical study\n5. Prior allogeneic bone marrow transplant within 12 months of screening date.\n6. Prior autologous stem cell transplant within 6 months of screening date.\n7. Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing.\n8. Active central nervous system (CNS) involvement by lymphoma, including untreated symptomatic epidural disease.\n9. Active uncontrolled infection.\n10. Poorly controlled depressive symptoms and\u002F or currently under management for depression that is poorly controlled.\n11. Significant disease or medical conditions, as assessed by the Investigator and Sponsor, that would substantially increase the risk benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV.\n12. Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which subjects are not on active anti-cancer therapies and have had no evidence of active malignancy for at least 1 year.\n13. History of major surgery within 3 weeks or minor surgery within 1 week of roflumilast administration. Major surgery includes, for example, any open or laparoscopic entry into a body cavity, or operative repair of fracture; minor surgery includes, for example, open surgical biopsy of palpable\u002Fsuperficial lymph node, or placement of vascular access device.\n14. Other medical or psychiatric illnesses or organ dysfunction, which in the opinion of the investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent.\n15. Corrected QT interval (QTc) prolongation (defined as a QTc \\>450 ms for males and \\>470 ms for females -Fridericia's correction-) or other clinically significant ECG abnormalities as assessed by the investigator.\n16. Baseline serum troponin above the upper limit of normal.\n17. Baseline serum brain natriuretic peptide (BNP )above the age-adjusted upper limit of normal.\n18. Baseline amylase above the upper limit of normal.\n19. Subjects known to be HIV-positive must not have multi-drug resistant HIV infection, cluster of differentiation 4 (CD4) counts \\\u003C 150\u002Fµl or other concurrent AIDS-defining conditions. Serologic screening for HIV is required within the 6 months prior to study enrollment.\n20. Subjects positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C-virus ribonucleic acid (HCV RNA), unless both AST and ALT≤1.25 x ULN and there is no known history of chronic active hepatitis.\n\n    Serologic screening for hepatitis B and C testing is required within the 6 months prior to study enrollment.\n21. Subjects with moderate or severe liver impairment, as defined by a Child-Pugh class of B or C.\n22. Women who are pregnant or breastfeeding.\n23. Current use of any of the following medications: boceprevir, carbamazepine, ciprofloxacin, cobicistat, conivaptan, enzalutamide, fluvoxamine, itraconazole, ketoconazole, mitotane, phenytoin, posaconazole, rifampin, ritonavir, St. John's Wort, telaprevir, voriconazole, or zafirlukast.\n24. Current use of non-nucleoside reverse transcriptase inhibitors (NNRTI) including efavirenz, rilpivirine, etravirine, delavirdine, nevirapine, and lersivirine.",{"count":74,"type":21},[76],"This study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants.\n\nThe aims are:\n\n1. To assess the safety and how well the participants tolerate the treatment\n2. Assess the response of the tumor to treatment to estimate complete response\n3. Assess the response of the tumor to treatment to estimate progression-free survival",[123],[279,280,281,282,283,284],"Lymphoid neoplasms","Loncastuximab","Rituximab","Roflumilast","Lo-RR-CHOP","R-CHOP","2026-06-18",{"date":287,"type":34},"2026-06-22",{"date":289,"type":34},"2025-06-20",{"date":291,"type":21},"2027-04-01",{"name":293,"class":89},"The University of Texas Health Science Center at San Antonio",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},"100449940","phase-2-a-study-of-zilovertamab-vedotin-mk-2140-in-combination-with-standard-of-care-in-participants-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-rrdlbcl-mk-2140-003-100449940","NCT05139017","A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)","A Phase 2\u002F3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)","Inclusion Criteria:\n\n* Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).\n* Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.\n* Has adequate organ function.\n* Is able to provide new or archival tumor tissue sample not previously irradiated.\n\nZilovertamab vedotin plus R-GemOx, or R-GemOx study arms:\n\n* Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.\n* Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy.\n\nNot applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms:\n\n* Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 2 lines of prior therapy.\n* Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy.\n\nExclusion Criteria:\n\n* Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL\n* Has received solid organ transplant at any time.\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).\n* Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication.\n* Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.\n* Has clinically significant pericardial or pleural effusion.\n* Has ongoing Grade \\>1 peripheral neuropathy.\n* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n* Has a demyelinating form of Charcot-Marie-Tooth disease.\n* Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction.\n* Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.\n* Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has ongoing corticosteroid therapy.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n* Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known active Hepatitis C virus infection.\n* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.",{"count":302,"type":21},290,[146,24],"The purpose of this Phase 2\u002F3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.\n\nWith protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \\[BR\\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.",[173,27],{"date":307,"type":34},"2026-06-23",{"date":309,"type":34},"2022-01-14",{"date":311,"type":21},"2027-09-24",{"name":40,"class":41},134,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":90},"100585172","hyperfractionated-dual-equivalent-fractionated-radiation-therapy-100585172","NCT06898905","Hyperfractionated Dual Equivalent Fractionated Radiation Therapy","Hyperfractionated Dual Equivalent Fractionated (HyDEF) Bridging Radiation Therapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Undergoing T-Cell Redirection Therapy","HyDEF","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Adult aged 18 years or older.\n4. Histologically confirmed diagnosis of R\u002FR DLBCL with plan for CAR T or BsAb therapy at Yale New Haven Hospital.\n5. ECOG performance status 0 to 3.\n6. Ability to present for once or twice daily (M-F) fractionated radiation therapy, without contraindications for radiotherapy as determined by the treating radiation oncologist.\n7. Women of childbearing potential must have a negative serum or urine pregnancy test at screening and at time of radiation treatment planning, per standard of care and departmental standard operating procedure. Participants must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Participants who are pregnant or currently breastfeeding.\n\n   a. Females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing potential.\n2. Participants with history of prior radiation exposure for research purposes within the past year, such that participation in this study would place them over the FDA limits for annual radiation exposure.\n3. Participants who are unable to safely receive FDG PET tracer.\n4. Any condition that would, in the investigator's judgment, interfere with full participation in the study and attending required study visits (if outpatient); pose a significant risk to the participant; or interfere with interpretation of study data.\n5. Participants who would not be anticipated to derive any clinical benefit from bridging radiotherapy, are unable to participate in twice daily radiotherapy, or have clinical contraindications to radiation therapy per treating investigator.",{"count":74,"type":21},[324],"NA","This study evaluates the feasibility and safety of bridging radiation therapy, including a novel method for comparing the effectiveness of hypofractionated versus hyperfractionated radiation therapy in participants with relapsed\u002Frefractory diffuse large B-cell lymphoma (R\u002FR DLBCL) undergoing T-cell redirection therapies (CAR T-cell therapy or bispecific antibodies).",[27],[320,328,329,330],"bridging radiation","once vs twice daily radiation","bulky disease lymphoma","2026-06-17",{"date":287,"type":34},{"date":334,"type":34},"2025-10-30",{"date":336,"type":21},"2027-04",{"name":338,"class":89},"Yale University",{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":347,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":132},"100543159","is-trogocytosis-a-predictive-marker-of-car-t-cell-response-in-diffuse-large-b-cell-lymphoma-100543159","NCT06352242","Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma?","La Trogocytose Est-elle un Marqueur prédictif de la réponse Aux Cellules CAR-T Dans Les Lymphomes Diffus à Grandes Cellules B ?","CARTROG","Inclusion Criteria:\n\n* For patients\n\n  * Patient who has given free and informed consent in writing for inclusion in the non-interventional CART-BANK protocol, and orally for the CARTROG protocol,\n  * Patients over 18 years of age at the time of inclusion,\n  * Diagnosis of LDGCB,\n  * Decision to treat with anti-CD19 CAR-T cells,\n  * Patient affiliated to or benefiting from a social security scheme.\n* For healthy volunteers:\n\n  * Given free and informed oral consent for inclusion in the CARTROG protocol,\n  * Donor between 18 and 70 years of age at the time of inclusion,\n  * No history of solid cancer or hematological malignancy,\n  * No known chronic pathology (e.g. hypertension, diabetes, etc.) and no daily treatment,\n  * No surgical treatment within the last 6 months.\n\nExclusion Criteria:\n\n* Patients who do not meet all the inclusion criteria,\n* Pregnant or breast-feeding patient,\n* Patient unable to follow the procedures and\u002For frequency of visits planned in the trial, for psychological, family, social or geographical reasons,\n* Patient unable to consent freely to inclusion, under guardianship, curatorship or safeguard of justice.",true,{"count":349,"type":21},85,[324],"CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R\u002FR). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Recent studies have shown that the level of trogocytosis by immune cells correlates with the persistence of tumor cells in patients with hematological malignancies. Our main objective is to identify a phenotypic \"signature\" of trogocytosis predictive of therapeutic response 6 months after injection of CAR-T cells for DLBCL.",[80],[354,355,356,357],"lymphoma","chimeric antigen receptor T-cell","trogocytosis","prognosis",{"date":287,"type":34},{"date":360,"type":34},"2024-05-22",{"date":362,"type":21},"2027-02-22",{"name":364,"class":89},"University Hospital, Montpellier",{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":393},"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 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":374,"type":21},645,[76,146],"Study consists of two main parts to explore BGB-16673 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)",[378,379,380,381,382,383,384,385,80],"B-cell Malignancy","Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma",{"date":285,"type":34},{"date":388,"type":34},"2021-09-13",{"date":390,"type":21},"2029-11",{"name":392,"class":41},"BeOne Medicines",127,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":411,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":90},"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":402,"type":21},36,[76],"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).",[406,407,385,380,408,409,80,384,410,381],"Refractory Non-Hodgkin Lymphoma","Burkitt Lymphoma","Lymphoplasmacytic Lymphoma","Primary Mediastinal Large B Cell Lymphoma","Transformed Lymphoma",[412],"CAR-T Therapy",{"date":287,"type":34},{"date":415,"type":34},"2020-09-11",{"date":417,"type":21},"2026-10-31",{"name":419,"class":89},"C. Babis Andreadis",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":439,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},"100370548","phase-1-a-study-of-tulmimetostat-dzr123-cpi-0209-in-patients-with-advanced-solid-tumors-and-lymphomas-100370548","NCT04104776","A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","A Phase 1\u002F2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","Key Inclusion Criteria:\n\nAll Patients:\n\n* Adults aged ≥18 years with life expectancy ≥12 weeks\n* ECOG performance status 0-1\n* Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)\n* Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds\n* Willingness to provide tumor tissue and blood samples for biomarker analyses\n* Agreement to protocol-specified contraception requirements\n* Signed informed consent prior to study procedures\n\nDisease-Specific Inclusion Criteria:\n\nPhase 1 (Dose Escalation):\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma\n* Disease refractory to standard therapy or with no available effective standard treatment\n* For prostate cancer: castrate testosterone levels maintained throughout the study\n\nPhase 2 (Disease-Specific Cohorts):\n\n* M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)\n* M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)\n* M3: ARID1A mutant recurrent\u002Fmetastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy\n* M4: Relapsed\u002Frefractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease\n* M5: Relapsed\u002Frefractory pleural or peritoneal mesothelioma with documented BAP1 loss\n* M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy\n* M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)\n* M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure\n\nKey Exclusion Criteria:\n\nAll Patients:\n\nMedical Conditions:\n\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Active or untreated symptomatic CNS metastases (with limited exceptions)\n* Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled infections or significant gastrointestinal disorders affecting absorption\n* Active HIV or hepatitis B\u002FC infection\n* Concurrent malignancy requiring active treatment (with protocol-defined exceptions)\n* Pregnancy, breastfeeding, or inability to comply with protocol requirements\n\nPrior or Concomitant Therapy:\n\n* Recent anticancer therapy within protocol-defined washout periods\n* Prior EZH2 inhibitor treatment\n* Recent radiation or liver-directed therapies outside allowed windows\n* Use of strong CYP3A4\u002F5 inhibitors or inducers\n\nAdditional Cohort-Specific Exclusions:\n\n* M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies\n* M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease",{"count":428,"type":21},275,[76,146],"The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.",[432,80,433,434,435,436,437,438],"Advanced Solid Tumor","Lymphoma, T-Cell","Mesothelioma, Malignant","Prostatic Neoplasms, Castration-Resistant","Endometrial Cancer","Ovarian Clear Cell Carcinoma","Metastatic Castration-resistant Prostate Cancer",[440,441,29,442,443,444,445,446,447,448,449,450,451,452,453,454,455,436,437,456,457,458,459],"Tulmimetostat","DZR123","Lymphoma, B-cell","Lymphoma, T-cell","Lymphoma, Non-Hodgkin","Lymphoma","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Topoisomerase Inhibitors","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents","Food effect","Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)","ARID1A wildtype (ARID1A WT) endometrial carcinoma","Metastatic castration-resistant prostate cancer (mCRPC)",{"date":287,"type":34},{"date":462,"type":34},"2019-09-18",{"date":464,"type":21},"2030-02-27",{"name":265,"class":41},81,{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":477,"briefSummary":478,"conditions":479,"keywords":480,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":489,"leadSponsor":491,"locationsCount":90},"100631948","phase-2-chidamide-maintenance-for-mrd-positive-double-expressor-dlbcl-in-first-complete-remission-100631948","NCT07507318","Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission","A Prospective, Multicenter, Single-Arm, Open-Label Phase 2 Study of Chidamide Maintenance in Patients With Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma Who Achieve Complete Response After Induction Therapy But Remain ctDNA MRD-Positive","DEL-MRD-CHID","Inclusion Criteria:\n\n* Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.\n* Double-expressor lymphoma confirmed by pathology, defined as MYC expression \\>=40% and BCL2 expression \\>=50% by immunohistochemistry.\n* Complete response after initial induction therapy.\n* Age \\>=18 and \\\u003C=80 years.\n* ECOG performance status 0-2.\n* No prior history of malignant tumor and no concurrent malignancy.\n* International Prognostic Index (IPI) score \\>1.\n* ctDNA MRD-positive at screening\u002Fenrollment.\n* Life expectancy of at least 6 months, in the opinion of the investigator.\n* Written informed consent provided before any study-specific procedure.\n\nExclusion Criteria:\n\n* Failure to achieve complete response after initial induction therapy.\n* Prior organ transplantation.\n* Uncontrolled coagulopathy or active bleeding.\n* Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction \\\u003C50%, connective tissue disease, or severe active infection.\n* Major organ surgery within 6 weeks before screening.\n* Screening laboratory abnormalities not attributable to lymphoma, including: neutrophil count \\\u003C1.5 x 10\\^9\u002FL; platelet count \\\u003C80 x 10\\^9\u002FL (or \\\u003C50 x 10\\^9\u002FL in patients with bone marrow involvement); total bilirubin \\>1.5 x upper limit of normal; ALT\u002FAST \\>2.5 x upper limit of normal, or \\>5 x upper limit of normal in patients with hepatic involvement; serum creatinine \\>1.5 x upper limit of normal.\n* Active hepatitis B not meeting protocol-defined virologic criteria for enrollment; patients with positive HBsAg or positive HBcAb require HBV DNA testing and must meet protocol-specified thresholds.\n* HIV infection.\n* Ongoing antitumor therapy for lymphoma or another malignancy.\n* Drug abuse or chronic alcohol abuse that may interfere with study evaluation.\n* Psychiatric illness or any condition resulting in inability to comply with the protocol.\n* Requirement for ongoing treatment with strong or moderate CYP3A inhibitors or inducers; patients exposed to these agents within 7 days before first study dose, or within fewer than 5 half-lives, are not eligible.\n* Inability to swallow capsules or clinically significant gastrointestinal disorders that may affect drug absorption, including malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial\u002Fcomplete bowel obstruction.\n* Any other uncontrolled medical condition that, in the investigator's judgment, may compromise safety, interfere with oral drug absorption or metabolism, or place the participant at excessive risk.",{"count":476,"type":21},69,[146],"This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual disease (MRD)-positive. Eligible participants will receive oral chidamide 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be assessed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The primary objectives are to evaluate ctDNA MRD negativity and 2-year progression-free survival. Secondary objectives include event-free survival, overall survival, and safety.",[27],[481,482,483,484,485],"Chidamide","Tucidinostat","Minimal Residual Disease","Maintenance Therapy","Double-Expressor Lymphoma","2026-06-16",{"date":285,"type":34},{"date":486,"type":34},{"date":490,"type":21},"2029-06-30",{"name":492,"class":89},"Rong Tao",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":500,"enrollmentInfo":501,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":504,"conditions":505,"keywords":506,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":90},"100302934","phase-1-venetoclax-ibrutinib-prednisone-obinutuzumab-and-revlimid-vipor-in-relapsedrefractory-b-cell-lymphoma-100302934","NCT03223610","Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","Phase 1b\u002F2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","* INCLUSION CRITERIA:\n* Patients must have histologically or cytologically confirmed B-cell lymphoma confirmed by the Laboratory of Pathology, NCI, as follows:\n\nPhase1b\n\n* Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as High-grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n\n  -Indolent B-cell lymphoma:\n* CLL\u002FSLL is excluded given alternative dosing of FDA-approved venetoclax for relapsed 17p CLL and increased risk of TLS with CLL\u002FSLL compared to other non-Hodgkin lymphomas.\n\n  * NOTE: Patients with known active CNS lymphoma are not eligible.\n\nPhase 2\n\n* Relapsed and\u002For refractory DLBCL and subtypes, including transformed lymphoma as well as High grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n* Relapsed and\u002For refractory Follicular lymphoma (FL)\n* Relapsed and\u002For refractory and untreated Mantle cell lymphoma (MCL)\n* Relapsed and\u002For refractory disease on at least 1 prior treatment regimen, as follows:\n\n  * Aggressive B-cell lymphoma:relapsed after and\u002For refractory to at least 1 prior anthracycline-containing regimen\n  * Indolent B-cell lymphoma: relapsed after and\u002For refractory to at least 1 prior anti-CD20 antibody-containing regimen.\n* NOTE: Patients with untreated and relapsed and\u002For refractory MCL will be included in the phase 2 MCL expansion.\n* Patients must have evaluable disease by clinical exam (i.e. palpable lymphadenopathy, measurable skin lesions, etc.), laboratory assessment (i.e. lymphoma involvement of bone marrow or peripheral blood by morphology, cytology or flow cytometry), and\u002For imaging (measurable lymph nodes or masses on CT or MRI and\u002For evaluable FDG-avid lesions on PET).\n* NOTE: Lesions that have been irradiated cannot be included in the tumor assessment unless unequivocal tumor progression has been documented in these lesions after radiation therapy.\n* Age greater than or equal to 18 years\n* NOTE: Because no dosing or adverse event data are currently available on the use of venetoclax in combination with ibrutinib, obinutuzumab, prednisone and Revlimid(R) in patients \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status less than or equal to 2\n* Adequate organ and marrow function as defined below unless dysfunction is secondary to lymphoma:\n\n  * absolute neutrophil count\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 1,000\u002FmcL\n  * hemoglobin\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 8 g\u002FdL\n  * platelets greater than or equal to 75,000\u002FmcL\n  * INR: less than or equal to 1.5 X institutional upper limit of normal (ULN) for patients not receiving therapeutic anticoagulation\n  * PTT\u002FaPTT: less than or equal to 1.5 X institutional ULN normal except if, in the opinion of the investigator, the aPTT is elevated because of a positive Lupus Anticoagulant\n  * Total Bilirubin: less than or equal to 1.5 X institutional ULN (or less than or equal to 3 X institutional ULN for patients with documented Gilberts syndrome)\n  * AST(SGOT)\u002FALT(SGPT): less than or equal to 2.5 X institutional ULN\n  * Serum Creatinine: less than or equal to 2.0mg\u002FdL OR\n  * Creatinine Clearance: greater than or equal to 60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above 2 mg\u002FdL\n\nCr Cl will be calculated with the use of the 24-hour creatinine clearance or modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass \\[IBM\\] instead of mass):\n\n(140 - Age) x IBM (kg) x \\[0.85 if female\\]\u002F 72 x serum creatinine (mg\u002FdL)\n\n\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n* Immune-modulating drugs (IMiDs) including Revlimid(R) are known to be teratogenic and potential embryo-fetal harm can be seen with use of venetoclax and ibrutinib. The effects of obinutuzumab on the developing human fetus is unknown. For these reasons, women of child-bearing potential and men must agree to use adequate contraception as described below.\n* For women of childbearing potential:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year as outlined below.\n  * Female subjects of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days and again within 24 hours prior to prescribing Revlimid(R) for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS(TM) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking Revlimid(R). FCBP must also agree to ongoing pregnancy testing.\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (greater than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n  * Examples of contraceptive methods with a failure rate of less than 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* For men:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of less than 1% per year as noted below. Men must refrain from donating sperm during this same period.\n  * With pregnant female partners, men must remain abstinent or use a condom as noted below to avoid exposing the embryo.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* Contraception Requirements:\n\nPre-Treatment\u002FDuring Treatment:\n\n--All Drugs- Women- begins 28 days prior to treatment; Men- Begins on day 1\n\nPost-Treatment:\n\n* Venetoclax- Women- 90 days; Men 90 days\n* Ibrutinib- Women- 3 months; Men- 3 months\n* Obinutuzumab- Women- 18 months; Men- 6 months\n* Revlimid- Women-28 days; Men- 28 days\n\n  * All study participants must be registered into the mandatory Revlimid REMS(TM) program and be willing and able to comply with the requirements of Revlimid REMS(TM). NOTE: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS(TM) program\n  * Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nThe following restrictions apply to current or prior anti-cancer treatment, prior to the first dose of study drug:\n\n* Patients who are actively receiving any other investigational agents.\n* Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug\n* Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug\n* Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment\n* Prior allogeneic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug\n* Not recovered (i.e., less than or equal to Grade 1 or baseline) from adverse events due to previously administered anti-cancer treatment, surgery, or procedure. NOTE: Exceptions to this include events not considered to place the subject at unacceptable risk of participation in the opinion of the PI (e.g., alopecia).\n\n  * Patients requiring the use of warfarin are excluded because of potential drug-drug interactions that may potentially increase the exposure of warfarin.\n  * Patients requiring the following agents within 7 days prior to the first dose of venetoclax are excluded:\n* Strong CYP3A inhibitors\n* Strong CYP3A inducers\n\nNOTE: Moderate CYP3A inhibitors and inducers should be used with caution and an alternative medication used, whenever possible.\n\nUncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n* Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\n* Uncontrolled and\u002For symptomatic thyroid disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to Cycle 1, Day 1;\n* Known infection with human T-cell leukemia virus 1 (HTLV-1)\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis; as well as active infection with HBV or HCV:\n\n  --Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\n* Patients with occult or prior HBV infection (defined as positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) with negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo HBV DNA testing during treatment and in surveillance for at least 12 months after completion of study therapy.\n* Malabsorption syndrome or other condition that precludes enteral route of administration\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women, or women who intend to become pregnant during the study, are excluded from this study because Revlimid(R) has known teratogenic effects and venetoclax, ibrutinib and obinutuzumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on study.\n* HIV-positive patients are ineligible because of the potential for pharmacokinetic interactions with venetoclax, ibrutinib and Revlimid(R) and combination antiretroviral therapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Evidence of active tumor lysis syndrome based on laboratory assessment\n* History of recent major surgery within 6 weeks prior to the start of Cycle 1, Day 1 other than for diagnosis\n* History of other active malignancy that could affect compliance with the protocol or interpretation of results\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible.\n  * Patients with a malignancy that has been treated with curative intent will also be eligible. Individuals in documented remission without treatment for greater than or equal to 2 years prior to enrollment may be included at the discretion of the investigator.\n* Known allergy to both xanthine oxidase inhibitors and rasburicase; or, known hypersensitivity to any of the study drugs","120 Years",{"count":502,"type":21},155,[76,146],"Background:\n\nB-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR).\n\nObjective:\n\nTo study the safety of ViPOR for people with B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after treatment\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood, urine, and heart tests\n* Tissue sample from previous procedure\n* Imaging scans\n* Registration for counseling on the risks of lenalidomide. They must get counseling at least every 28 days.\n\nParticipants will have a bone marrow aspiration before treatment.\n\nParticipants may have tumor samples taken.\n\nParticipants will get ViPOR in 21-day cycles. For up to 6 cycles:\n\n* Participants will get one drug by IV on days 1 and 2.\n* Participants will take the other four drugs by mouth on most days. After their first dose of venetoclax, they will stay in the clinic for at least 8 hours and return the next day for monitoring. They may be admitted for more drugs or monitoring.\n\nParticipants will keep a drug diary.\n\nParticipants will have a physical exam and blood and urine tests at least once per cycle. They will have scans 4 times over 6 cycles.\n\nParticipants will have a visit about 1 month after their last dose of study drug. They will then have visits every few months for 3 years, and once a year for years 4 and 5. Visits include a physical exam, blood tests, and scans.",[445,381,27,407],[179,507],"Dose-Finding",{"date":331,"type":34},{"date":510,"type":34},"2018-02-09",{"date":512,"type":21},"2027-12-01",{"name":187,"class":188},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":526,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":90},"100561782","phase-1-r-cmop-in-patients-with-newly-diagnosed-diffuse-large-b-cell-lymphoma-100561782","NCT06594640","R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma","A Multicenter, Prospective Phase I\u002FII Trial to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome in Combination With Cyclophosphamide, Vincristine, Prednisone, and Rituximab in Patients With Newly Diagnosed DLBCL","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically confirmed newly diagnosed diffuse large B-cell lymphoma;\n3. Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy;\n4. There must be at least one measurable lesion per the Lugano2014 criteria；\n5. For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose (18FDG) PET-CT positive；\n6. Ann Arbor stages II-IV；\n7. ECOG score 0\\~2；\n8. Expected survival time ≥3 months;\n9. a.)Patients should meet the following requirements and must not have received treatment with cell growth factors or blood products within 14 days prior to the hematology test: Absolute value of neutrophils ≥ 1.5 × 10\\^9\u002FL; Platelet ≥ 75 × 10\\^9\u002FL; Hemoglobin≥80g\u002FL. For patients with bone marrow involvement of lymphoma, the requirements are adjusted as follows: Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL; Platelet count ≥ 50 × 10\\^9\u002FL; Hemoglobin level ≥ 75 g\u002FL.\n\n   b.)Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST and ALT ≤ 5 × ULN for patients with liver involvement. Total bilirubin ≤1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome); c.)Creatinine clearance ≥ 50 mL\u002Fmin or serum creatinine ≤ 2× ULN; d.)Coagulation function: prothrombin time or activated partial thromboplastin time≤ 1.5 × ULN, and international normalized ratio ≤ 1.5;\n10. Female patients of childbearing age must have a negative pregnancy test at the time of enrollment within one week. And patients must agree to use an effective method of contraception from the study initiation until at least 12 months after the last treatment;\n11. Able to understand and comply with the study, and voluntarily sign informed consent; -\n\nExclusion Criteria:\n\n1. Primary central nervous system DLBCL, Primary testicular large B-cell lymphoma, Primary mediastinal (thymic) large B-cell lymphoma, Lymphomatoid granulomatosis, ALK-positive large B-cell lymphoma, Plasmablastic lymphoma, HHV8-positive DLBCL, Primary effusion lymphoma, Intravascular large B-cell lymphoma, B-cell lymphoma unclassifiable between DLBCL and classical Hodgkin lymphoma, T-cell\u002Fhistiocyte-rich large B-cell lymphoma, and High-grade B-cell lymphoma；\n2. transformed indolent lymphoma ;\n3. Patients with active central nervous system involvement;\n4. History of hematopoietic stem cell transplantation;\n5. Have received prior anti-lymphoma treatment, excluding short-term or low-dose corticosteroids.;\n6. Used any NMPA-approved anticancer herbal medicines or proprietary Chinese medicines within 14 days prior to the first dose;\n7. History of allergy and contraindications to the same class and excipients of the experimental drug;\n8. Participating in any other intervention clinical trials within 4 weeks prior to the first dose except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study;\n9. Active bacterial or viral infections requiring systemic or intravenous drug treatment.\n10. History of immunodeficiency, including anti-HIV positive;\n11. Active hepatitis B and C infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than the Upper limit of normal(ULN); Hepatitis C virus antibody positive and hepatitis C virus RNA higher than the Upper limit of normal);\n12. syphilis infection;\n13. Individuals with an underlying medical condition, alcohol or drug abuse or dependence that impedes study drug administration or interferes with interpretation of study drug toxicity and AE, or results in inadequate or reduced adherence to the study;\n14. Patients with interstitial lung disease that requires treatment; 15: A history of severe cardiovascular disease, including but not limited to:\n\n    1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or second to third-degree atrioventricular (AV) block;\n    2. A mean QTcF interval longer than 450 ms, based on three 12-lead ECGs taken at rest;\n    3. Acute coronary syndrome, congestive heart failure, stroke, or any other Grade 3 or higher cardiovascular event occurring within 6 months prior to the first dose of therapy;\n    4. NYHA functional class ≥ II or left ventricular ejection fraction (LVEF)lower than 50%;\n    5. Any factors that increase the risk of QTc prolongation or arrhythmias, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome or unexplained sudden death in a first-degree relative under the age of 40, or concurrent use of any medications known to prolong the QT interval;\n    6. uncontrolled hypertension;\n\n16\\. History of other malignant tumor within 2 years, except for DLBCL in this trial or resected locally cancer that has been cured (e.g.basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast); 17. No psychological, spiritual potentially hampering compliance with the study protocol and follow-up schedule; 18. Women who are pregnant or breastfeeding; 19. Any other reasons deemed by the investigator to render the participant unsuitable for inclusion in this clinical trial.\n\n\\-",{"count":522,"type":21},108,[76,146],"This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma",[123],[527,123],"Mitoxantrone hydrochloride liposome injection","2026-06-08",{"date":530,"type":34},"2026-06-10",{"date":532,"type":34},"2024-05-30",{"date":534,"type":21},"2027-07-30",{"name":536,"class":89},"Institute of Hematology & Blood Diseases Hospital, China",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":545,"enrollmentInfo":546,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":551,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":569},"100427350","phase-2-efficacy-and-safety-of-mb-cart20191-vs-soc-in-lymphoma-patients-100427350","NCT04844866","Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients","A Pivotal Phase II Randomised, Multi-centre, Open-label Study to Evaluate the Efficacy and Safety of MB-CART2019.1 Compared to SoC Therapy in Participants With r\u002Fr DLBCL, Who Are Not Eligible for HDC and ASCT","DALY 2-EU","Part I:\n\n1. Histologically proven DLBCL and associated subtypes, according to the World Health Organization (WHO) 2016 classification including:\n\n   * DLBCL not otherwise specified (NOS).\n   * High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and\u002For BCL6 rearrangements with DLBCL\u002Fblastoid\u002Fintermediate histology or HGBL with MYC and BCL2 and\u002For BCL6 rearrangements (double hit lymphoma\u002Ftriple hit lymphoma).\n   * High-grade BCL, NOS.\n   * Primary (thymic) large mediastinal BCL.\n   * Disease transformed from an earlier diagnosis of low-grade lymphoma (e.g. an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with DLBCL disease progression subsequent to DLBCL-directed systemic treatment.\n   * Follicular lymphoma Grade 3B.\n2. Relapsed or refractory disease after first-line chemoimmunotherapy:\n\n   * Refractory disease defined as no CR to first-line therapy (e.g. R-CHOP \\[rituximab, cyclophosphamide, daunorubicin, vincristine and prednisone\\]).\n\n     * Progressive disease (PD) after at least 2 full cycles of first-line therapy.\n     * Stable disease (SD) after 4 cycles of first-line therapy.\n     * PR as best response after at least 6 cycles of first-line therapy and biopsy-proven persistent disease (except where prohibited due to comorbidities) within ≤ 24 months from the start of the first-line therapy.\n   * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease progression (except where prohibited due to comorbidities) within ≤ 24 months from the start of the first-line therapy.\n3. Participants must have received adequate first-line therapy containing at least the combination of an anthracycline-based regimen and rituximab (anti-CD20 monoclonal antibody). Local therapies (e.g. radiotherapies) will not be considered as line of therapy if performed during the same line of treatment.\n4. Archival paraffin-embedded tumour tissue acquired ≤ 2 years (preferred: ≤ 2 months) prior to screening for the central pathology review to confirm DLBCL diagnosis must be made available for participation in this study. If archival paraffin-embedded tumour tissue is not available, fresh tumour tissue sample (preferred) or core-needle biopsy must be made available for the central pathology review.\n5. Participants deemed ineligible to receive HDC followed by ASCT based on the treating physician's assessment and meeting the following criteria:\n\n   EITHER\n   * Age ≥ 18 years and\n\n     * Prior ASCT (as first-line consolidation) or\n     * Haematopoietic cell transplantation-specific comorbidity index (HCT-CI) \\> 3. OR\n   * Age ≥ 65 years and ≥ 1of the criteria below:\n\n     * Impaired cardiac function (left ventricular ejection fraction \\[LVEF\\] \\\u003C 50%), or\n     * Impaired renal function (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 60 mL\u002Fmin) calculated according to the modified Modification of Diet in Renal Disease (MDRD) formula, or\n     * Impaired pulmonary function (diffusing capacity for carbon monoxide or forced expiratory volume in 1 second \\\u003C 80%) or dyspnoea on slight activity, or\n     * Eastern Cooperative Oncology Group (ECOG) performance status \\> 1. OR\n   * Age ≥ 70 years. Documentation of the reason for ineligibility for ASCT must be present in the participant's source data.\n\n   In addition, all participants must fulfil the following criteria:\n6. Age ≥ 18 years.\n7. Measurable disease according to Lugano criteria. The lesion must be measurable (nodes \\> 1.5 cm in the long axis; extranodal lesions \\> 1 cm in the long axis) and positive on a positron emission tomography scan.\n8. Estimated life expectancy of \\> 3 months for other reasons than the primary disease.\n9. Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures (Pearl index \\\u003C 1) or practice true sexual abstinence from any heterosexual intercourse (True abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.) or must have a vasectomised partner as the sole sexual partner (The vasectomised partner must have received medical assessment of the surgical success.) for at least 1 month before the study start, during the study and in the 12 months following the last dose of study treatment. A woman is considered a WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Highly effective methods of contraception include hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or systems (e.g. hormonal and non-hormonal) and bilateral tubal occlusion. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. WOCBP who want to become pregnant after completing treatment should seek advice about oocyte cryoconservation prior to treatment because of possible irreversible infertility. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment.\n\n   Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive measures (Pearl index \\\u003C 1, e.g. spermicide and condom or other highly effective contraceptive measures (Pearl index \\\u003C 1) taken by their WOCBP partner) or practice true sexual abstinence from any heterosexual intercourse (True abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.), unless they are surgically sterile (meaning at least 2 consecutive analyses following vasectomy demonstrate absence of sperms in the ejaculate), during the study and in the 12 months following the last dose of study treatment. Men should seek advice about sperm conservation prior to treatment because of possible irreversible infertility. Men must furthermore refrain from sperm donation throughout the study until 12 months after the last administration of study treatment.\n10. In the opinion of the investigator, the participant must be able to comply with all study-related procedures, medication use and evaluations.\n11. Mental capacity and legal ability to consent to participation in the clinical study.\n\nCriteria for Exclusion:\n\n1. Contraindications for R-GemOx, BR plus polatuzumab vedotin, cyclophosphamide and fludarabine as judged by the treating physician.\n2. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.\n3. Participants who have received more than one line of treatment for DLBCL or associated subtypes.\n4. Prior haematopoietic stem cell transplantation (HSCT; as first-line consolidation) \\\u003C 3 months at the time of leukapheresis.\n5. ECOG performance status \\> 2.\n6. Absolute neutrophil count \\\u003C 1,000\u002FμL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy).\n7. Platelet count \\\u003C 50,000\u002FμL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy).\n8. Absolute lymphocyte count \\\u003C 100\u002FμL.\n9. Participants who have central nervous system (CNS) lymphoma involvement in present or past medical history.\n10. Participants with the requirement for urgent therapy due to tumour mass effects.\n11. Infection with human immunodeficiency virus.\n12. Presence of active or prior hepatitis B or C as indicated by serology (for detailed criteria see Section 10.2.7.10). Treated infection with hepatitis B or C virus unless confirmed to be polymerase chain reaction negative.\n13. Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n14. Active, severe systemic fungal, viral or bacterial infection.\n15. Known history or evidence of severely immunocompromised state, i.e. corticosteroid treatment \\> 10 mg\u002Fday for more than 6 months.\n16. Has received vaccination with live virus vaccines 6 weeks prior to randomisation.\n17. Prior CD19-targeted therapy.\n18. Known history or presence of seizure activities or on active anti-seizure medications within the previous 12 months.\n19. History or presence of non-malignant CNS disease that, in the judgement of the investigator, may impair the ability to evaluate neurotoxicity.\n20. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease.\n21. Known history or presence of cerebral vascular accident (CVA) within 12 months prior to randomisation.\n\n    Note: In case of history of CVA \\> 12 months prior to leukapheresis, then the participant must not have any unstable or life-threatening neurological deficits.\n22. Participants with Richter's transformation or Richter's syndrome.\n23. Participants who are concurrently on any other experimental treatments or during the previous 4 weeks or 5 half-lives.\n24. Clinical heart failure with New York Heart Association class ≥ 2 or LVEF \\\u003C 30% or severe cardiac arrhythmias or QT prolongation (resting QTcF ≥ 450 msec \\[male\\] or ≥ 460 msec \\[female\\] at screening) that would (according to the evaluation of the investigator) face an uncontrollable risk by receiving the medications administered in the trial.\n25. Resting peripheral oxygen saturation \\\u003C 90% on room air.\n26. Liver dysfunction as indicated by total bilirubin \\> 2.5 × institutional upper limit of normal (ULN), aspartate aminotransferase and\u002For alanine aminotransferase \\> 5 × ULN or typical symptoms like jaundice.\n27. Serum creatinine ≥ 2.0 × ULN or eGFR \\\u003C 30 mL\u002Fmin calculated according to the modified MDRD formula.\n28. Pregnant or breast-feeding women.\n29. Prior history of malignancies other than DLBCL. Exceptions include participants who have been free of the disease for ≥ 3 years prior to screening and participants with adequately treated and removed basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, carcinoma in situ of the bladder or incidental histological finding of untreated localised (T1a, T1b or T1c) prostate cancer under surveillance.\n30. History of severe immediate hypersensitivity to any investigational medicinal product (IMP), auxiliary medicinal product (AxMP), premedication or rescue medication or its excipients that is scheduled to be given during study participation.\n31. Major surgery less than 30 days before start of treatment.\n32. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.\n\nPart II:\n\n1. Histologically proven DLBCL and associated subtypes, according to the WHO 2016 classification including:\n\n   * DLBCL, NOS.\n   * HGBL with MYC and BCL2 and\u002For BCL6 rearrangements with DLBCL\u002Fblastoid\u002Fintermediate histology or HGBL with MYC and BCL2 and\u002For BCL6 rearrangements (double hit lymphoma\u002Ftriple hit lymphoma).\n   * High-grade BCL, NOS.\n   * Primary (thymic) large mediastinal BCL.\n   * Disease transformed from an earlier diagnosis of low-grade lymphoma (e.g., an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with DLBCL disease progression subsequent to DLBCL-directed systemic treatment.\n   * Follicular lymphoma Grade 3B.\n2. Relapsed or refractory disease after first-line chemoimmunotherapy:\n\n   * Refractory disease defined as no CR to first-line therapy (e.g., R-CHOP).\n\n     * PD after at least 2 full cycles of first-line therapy.\n     * SD after 4 cycles of first-line therapy.\n     * PR as best response after at least 6 cycles of first-line therapy and biopsy-proven persistent disease (except where prohibited due to comorbidities) within ≤ 12 months after completion of first-line treatment.\n   * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease progression (except where prohibited due to comorbidities) within ≤ 12 months after completion of first-line treatment.\n3. Participant must have received adequate first-line therapy containing at least the combination of an anthracycline-based regimen and rituximab (anti-CD20 monoclonal antibody). Local therapies (e.g., radiotherapies) will not be considered as line of therapy if performed during the same line of treatment.\n4. Archival paraffin-embedded tumour tissue acquired ≤ 2 years (preferred: ≤ 2 months) prior to screening for the central pathology review to confirm DLBCL diagnosis must be made available for participation in this study. If archival paraffin-embedded tumour tissue is not available, fresh tumour tissue sample (preferred) or core-needle biopsy must be made available for the central pathology review.\n5. Measurable disease according to Lugano criteria. The lesion must be measurable (nodes \\> 1.5 cm in the long axis; extranodal lesions \\> 1 cm in the long axis) and positive on a positron emission tomography scan.\n6. Approved treatment options not suitable according to investigator's assessment.\n\n   In addition, all participants must fulfil the following criteria:\n7. Age ≥ 18 and ≤ 70 years.\n8. Estimated life expectancy of \\> 3 months for other reasons than the primary disease.\n9. ECOG 0-1.\n10. Adequate bone marrow function, defined as:\n\n    * Absolute neutrophil count ≥ 1,000\u002FμL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy).\n    * Platelet count ≥ 50,000\u002FμL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy).\n    * Absolute lymphocyte count ≥ 100\u002FμL.\n11. Adequate organ function, defined as:\n\n    * New York Heart Association class \\\u003C 2 or LVEF ≥ 50%.\n    * No severe cardiac arrhythmias or QT prolongation (resting QTcF \\\u003C 450 msec \\[male\\] or \\\u003C 460 msec \\[female\\] at screening).\n    * No clinically relevant pleural effusion or pericardial effusion.\n    * Resting peripheral oxygen saturation ≥ 92% on room air.\n    * Total bilirubin ≤ 2.0 × ULN, AST and\u002For ALT ≤ 5 × ULN\n    * Serum creatinine \\\u003C 1.0 × ULN or eGFR (according to modified MDRD formula) ≥ 60 mL\u002Fmin.\n12. WOCBP must agree to use highly effective contraceptive measures (Pearl index \\\u003C 1) or practice true sexual abstinence from any heterosexual intercourse (True abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.) or must have a vasectomised partner as the sole sexual partner (The vasectomised partner must have received medical assessment of the surgical success.) for at least 1 month before the study start, during the study and in the 12 months following the last dose of study treatment. A woman is considered a WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Highly effective methods of contraception include hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or systems (e.g., hormonal and non-hormonal) and bilateral tubal occlusion. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. WOCBP who want to become pregnant after completing treatment should seek advice about oocyte cryoconservation prior to treatment because of possible irreversible infertility. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment. Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive measures (Pearl index \\\u003C 1, e.g., spermicide and condom or other highly effective contraceptive measures (Pearl index \\\u003C 1) taken by their WOCBP partner) or practice true sexual abstinence from any heterosexual intercourse (True abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.), unless they are surgically sterile (meaning at least 2 consecutive analyses following vasectomy demonstrate absence of sperms in the ejaculate), during the study and in the 12 months following the last dose of study treatment. Men should seek advice about sperm conservation prior to treatment because of possible irreversible infertility. Men must furthermore refrain from sperm donation throughout the study until 12 months after the last administration of study treatment.\n13. In the opinion of the investigator, the participant must be able to comply with all study-related procedures, medication use and evaluations.\n14. Mental capacity and legal ability to consent to participation in the clinical study.\n\nCriteria for Exclusion:\n\n1. Contraindications for cyclophosphamide and fludarabine as judged by the treating physician.\n2. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.\n3. Participants who have received more than one line of prior therapy for DLBCL or associated subtypes.\n4. Prior HSCT (as first-line consolidation) \\\u003C 3 months at the time of leukapheresis.\n5. Participants who have CNS lymphoma involvement in present or past medical history.\n6. Participants with the requirement for urgent therapy due to tumour mass effects.\n7. Infection with human immunodeficiency virus.\n8. Presence of active or prior hepatitis B or C as indicated by serology. Treated infection with hepatitis B or C virus unless confirmed to be polymerase chain reaction negative.\n9. Infection with Treponema pallidum (pathogen causing syphilis).\n10. Infection with human T-lymphotropic virus 1.\n11. Active infection with SARS-CoV-2.\n12. Active, severe systemic fungal, viral, or bacterial infection.\n13. Known history or evidence of severely immunocompromised state, i.e. corticosteroid treatment \\> 10 mg\u002Fday for more than 6 months.\n14. Has received vaccination with live virus vaccines within 6 weeks prior to randomisation.\n15. Prior CD19-targeted therapy.\n16. Known history or presence of seizure activities or on active anti-seizure medications within the previous 12 months.\n17. History or presence of non-malignant CNS disease that, in the judgement of the investigator, may impair the ability to evaluate neurotoxicity.\n18. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease.\n19. Known history or presence of CVA within 12 months prior to randomisation. Note: In case of history of CVA \\> 12 months prior to leukapheresis, then the participant must not have any unstable or life-threatening neurological deficits.\n20. Participants with Richter's transformation or Richter's syndrome.\n21. Participants who are concurrently on any other experimental treatments or during the previous 4 weeks or 5 half-lives.\n22. Pregnant or breastfeeding woman.\n23. Prior history of malignancies other than DLBCL. Exceptions include participants who have been free of the disease for ≥ 3 years prior to screening and participants with adequately treated and removed basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, carcinoma in situ of the bladder or incidental histological finding of untreated localised (T1a, T1b or T1c) prostate cancer under surveillance.\n24. History of severe immediate hypersensitivity to any IMP, AxMP, premedication or rescue medication or its excipients that is scheduled to be given during study participation.\n25. Major surgery less than 30 days before start of treatment.\n26. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.","70 Years",{"count":547,"type":21},213,[146],"In the current protocol version, there are two parts. Part I is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed\u002Frefractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.\n\nPart II is a Phase II single-arm, open-label, multi-centre study evaluating the efficacy and safety of MB-CART2019.1 in younger, fit participants with R-R DLBCL. Part II will start after completion of enrolment in Part I.",[123],[552,553,554,555,556,557,123,173,381,174,558,559,560,561],"CAR T cells","chimeric antigen receptor","MB-CART2019.1","CD20","CD19","relapsed refractory","zamtocabtagene autoleucel","blood cancer","LBCL","Follicular Lymphoma 3B",{"date":530,"type":34},{"date":564,"type":34},"2021-08-18",{"date":566,"type":21},"2031-09-30",{"name":568,"class":41},"Miltenyi Biomedicine GmbH",51,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":577,"maxAge":578,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":593},"100546451","phase-1-substudy-01a-zilovertamab-vedotin-in-pediatric-and-young-adult-participants-with-hematologic-malignancies-or-solid-tumors-mk-9999-01alightbeam-u01-100546451","NCT06395103","Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A\u002FLIGHTBEAM-U01)","LIGHTBEAM-U01 Substudy 01A: A Phase 1\u002F2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL\u002FBurkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.\n* For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.\n\nExclusion Criteria:\n\n* History of solid organ transplant.\n* Clinically significant (ie, active) cardiovascular disease.\n* Known history of liver cirrhosis.\n* Ongoing Grade \\>1 peripheral neuropathy.\n* Demyelinating form of Charcot-Marie-Tooth disease.\n* Diagnosed with Down syndrome.\n* Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.\n* History of human immunodeficiency virus (HIV) infection.\n* Contraindication or hypersensitivity to any of the study intervention components.\n* Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.\n* Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).\n* Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and\u002For cytoreductive therapy with steroids\u002Fhydroxyurea.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Known additional malignancy that is progressing or has required active treatment within the past 1 year.\n* Active infection requiring systemic therapy.\n* Known history of Hepatitis B or known active Hepatitis C virus infection.\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.","6 Months","25 Years",{"count":580,"type":21},90,[76,146],"Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)\u002FBurkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.",[249,123,407,584,585],"Neuroblastoma","Ewing Sarcoma","2026-06-04",{"date":528,"type":34},{"date":589,"type":34},"2024-08-16",{"date":591,"type":21},"2029-03-31",{"name":40,"class":41},70,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":609,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"100194258","phase-3-a-long-term-extension-study-of-pci-32765-ibrutinib-100194258","NCT01804686","A Long-term Extension Study of PCI-32765 (Ibrutinib)","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":603,"type":21},700,[24],"The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.",[383,384,385,380,123,607,608],"Waldenstrom Macroglobulinemia","Chronic Graft Versus Host Disease",[610,611,612,613,614,615,616,617,618,619],"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",{"date":621,"type":34},"2026-06-05",{"date":623,"type":34},"2013-09-09",{"date":625,"type":21},"2029-12-31",{"name":627,"class":41},"Janssen Research & Development, LLC",175,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":22,"phases":639,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":90},"100633566","phase-1-external-beam-radiotherapy-followed-by-bispecific-antibody-therapy-for-relapsedrefractory-dlbcl-100633566","NCT07528352","External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed\u002FRefractory DLBCL","REBEL: A Phase 1b Study on the Safety and Feasibility of External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed\u002FRefractory DLBCL","REBEL","Inclusion Criteria:\n\n* Participant aged ≥ 18 years\n* Disease criteria:\n\n  * Histologically confirmed large b-cell lymphoma (LBCL), including DLBCL not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma with:\n  * Relapsed or refractory disease with at least 2 prior systemic therapies\n* Must be a candidate for radiation therapy up to 20 Gy. Radiation therapy to up to 3 lesions will be permitted.\n* Must have at minimum two sites of evaluable disease per Lugano 2014, including one site that will not be irradiated as part of this study and has not received radiation therapy in the past.\n* ECOG Performance Status ≤ 3\n* Adequate organ function as defined as\n\n  --Hematologic:\n  * Absolute neutrophil count ≥ 1000\u002Fmm3 (Note: Use of G-CSF is permitted)\n  * Platelet count ≥ 50,000\u002Fmm3 (Note: Use of platelet transfusions is permitted)\n  * Hemoglobin ≥ 7 g\u002FdL, (Note: Blood transfusions are permitted)\n\n    --Hepatic:\n  * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN ----Participants with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.\n\n    --Renal:\n  * Estimated creatinine clearance ≥ 40 mL\u002Fmin by Cockcroft-Gault formula.\n* Participants must adhere to the following sex and contraceptive\u002Fbarrier requirements:\n\n  * If participant is of childbearing potential they must have a negative pregnancy test\n  * For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n  * \\\u003C 50 years of age: ---Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution --≥ 50 years of age:\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and lactation requirements as described in Sections 5.4.1 and 5.4.2.\n* Clinically significant adverse effects from any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the Investigator.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* Currently receiving any other approved or investigational therapy considered as a treatment for lymphoma with the exception of corticosteroids.\n* Progressive disease on prior CD20 x CD3 bispecific antibody\n\n  --Note: Prior therapy with CD20 x CD3 bispecific antibody is allowed.\n* Prior systemic anti-cancer therapy which may have delayed treatment effects (e.g. immunotherapy) ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.\n* The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.\n* Known brain metastases or cranial epidural disease.\n\n  --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and\u002For surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry\n* Significant medical diseases or other conditions, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study.\n* Active systemic bacterial, viral, fungal or other infection requiring systemic treatment at time of screening.\n* Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.\n\n  --Note: Participants on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.\n* Hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.\n\n  --Note: Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n* Unable to tolerate corticosteroids\n* Participants taking prohibited medications as described in Section 6.6.1.",{"count":638,"type":21},12,[76],"The purpose of this clinical trial is to assess the safety and tolerability of ration therapy followed by receiving epcoritamab or glofitamab in patients with relapsed\u002Frefractory diffuse large B-cell lymphoma.",[80],"2026-06-02",{"date":586,"type":34},{"date":645,"type":34},"2026-06-01",{"date":647,"type":21},"2031-06",{"name":88,"class":89},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":242,"maxAge":656,"enrollmentInfo":657,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":659,"conditions":660,"keywords":675,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":683,"locationsCount":685},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212","NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has 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 venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","38 Years",{"count":658,"type":21},30,"The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[661,662,445,663,17,664,665,666,667,668,669,670,80,380,407,671,672,673,674],"Hematologic Malignancy","Leukemia","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","AML","Chronic Myelogenous Leukemia","CML","Myeloproliferative Neoplasm","Non Hodgkin Lymphoma","Hodgkin Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[676,677,678],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML",{"date":586,"type":34},{"date":681,"type":34},"2023-11-15",{"date":512,"type":21},{"name":684,"class":89},"Children's Hospital Medical Center, Cincinnati",5]