[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-b-cell-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,63,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100640327","phase-2-pirtobrutinib-maintenance-after-car-t-therapy-in-relapsed-or-refractory-b-cell-lymphoma-100640327",false,"NCT07622784","Pirtobrutinib Maintenance After CAR-T Therapy in Relapsed or Refractory B-Cell Lymphoma","A Single-Arm, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pirtobrutinib as Maintenance Therapy for Relapsed or Refractory B-Cell Lymphoma After CAR-T Cell Therapy","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the informed consent form.\n* Age 18 years or older, male or female.\n* Histologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or transformed follicular lymphoma (tFL).\n* Eastern Cooperative Oncology Group performance status of 0 to 2.\n* Has received commercial anti-CD19 CAR-T cell therapy, with informed consent obtained before Day 28 after CAR-T cell infusion.\n* Prior anti-lymphoma therapy-related adverse events, especially CAR-T-related adverse events, have stabilized and recovered to Grade 1 or lower, except for clinically insignificant toxicities.\n\nExclusion Criteria:\n\n* History of other malignancies, except non-melanoma skin cancer without recurrence for more than 3 years, carcinoma in situ, such as cervical, bladder, or breast carcinoma, or follicular lymphoma.\n* Prior autologous or allogeneic hematopoietic stem cell transplantation.\n* Active or suspected uncontrolled fungal, bacterial, viral, or other infection requiring intravenous treatment. Patients with uncomplicated urinary tract infection or uncomplicated bacterial pharyngitis may be enrolled if responding to active treatment.\n* History of immunodeficiency, including human immunodeficiency virus infection; positive treponema pallidum antibody; active hepatitis B virus infection; or active hepatitis C virus infection.\n* Current or prior history of benign central nervous system disease, such as seizure, cerebrovascular ischemia or hemorrhage, dementia, cerebellar disease, or any central nervous system-related autoimmune disease.\n* Lymphoma involvement of the atrium or ventricle.\n* Autoimmune disease requiring systemic immunosuppressive or immunomodulatory therapy within 2 years.\n* History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment.\n* Any comorbidity that may affect or interfere with safety or efficacy assessment.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of pirtobrutinib as maintenance therapy in patients with relapsed or refractory B-cell lymphoma after commercial anti-CD19 CAR-T cell therapy.",[26],"Relapsed or Refractory B-cell Lymphoma","NOT_YET_RECRUITING","2026-05-28",{"date":30,"type":31},"2026-06-03","ACTUAL",{"date":33,"type":20},"2026-06",{"date":35,"type":20},"2028-12",{"name":37,"class":38},"Sun Yat-sen University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":39},"100501232","phase-4-secondary-infusion-of-relma-cel-injection-for-relapsed-or-refractory-b-cell-lymphoma-100501232","NCT05806580","Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma","A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma","Inclusion Criteria:\n\n* Patients have signed an Informed Consent Form (ICF).\n* Adults diagnosed with relapsed or refractory B-cell lymphoma who have completed initial treatment with Relma-cel.\n* Patients must have undergone at least one disease assessment post-initial Relma-cel treatment, and the investigator decides to administer a second treatment (including PR\u002FPD\u002FSD) based on clinical practice.\n* Before the second infusion, confirm that the prepared dose of relma-cel is sufficient (recommended 80-150 x 10\\^6 CAR-T cells), with specific dosage determined by the investigator based on patient condition and dose availability.\n* Confirm the presence of CD19+ residual tumor tissue, if clinically permissible.\n* Measure plasma for the absence of anti-drug antibodies (ADA) to relma-cel before the second treatment.\n* Toxicity related to lymphodepleting chemotherapy (fludarabine and cyclophosphamide), except for hair loss, must have resolved to ≤ Grade 1 or returned to baseline levels before retreatment.\n* Patients must not have experienced severe adverse reactions during the first treatment, or any adverse reactions must have resolved to baseline levels from the first treatment.\n\nExclusion Criteria:\n\n* Patients with hypersensitivity to active ingredients or any excipients (e.g., dimethyl sulfoxide, compound electrolyte injection, human albumin).\n* Patients with uncontrolled systemic fungal, bacterial, viral, or other infections",{"count":48,"type":20},8,[50],"PHASE4","To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.",[26],"RECRUITING","2024-10-21",{"date":56,"type":31},"2024-10-23",{"date":58,"type":31},"2023-05-01",{"date":60,"type":20},"2027-12-31",{"name":62,"class":38},"Ruijin Hospital",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":75,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":39},"100520905","phase-2-selinexor-combined-with-r-gdp-regimen-for-tp53-altered-rr-dlbcl-100520905","NCT06062641","Selinexor Combined With R-GDP Regimen for TP53-altered R\u002FR DLBCL","Selinexor Combined With R-GDP Regimen for TP53-altered Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma: a Single Arm, Single Center, Phase II Study","Inclusion Criteria:\n\n1. Age≥18\n2. Pathologically confirmed primary DLBCL or previously diagnosed indolent lymphoma (e.g., follicular lymphoma) transformation to DLBCL with TP53 deletion or mutation confirmed by FISH or next-generation sequencing.\n3. Received at least 1 but no more than 3 previous lines of systemic therapy for DLBCL, and was relapsed or refractory to the last line of therapy Salvage chemoimmunotherapy and subsequent stem cell transplantation are considered the same first-line systemic therapy Maintenance therapy will not be counted separately as first-line systemic therapy Radiotherapy for curative treatment of localized DLBCL lesions does not count as first-line systemic therapy\n4. Presence of measurable positron-emission tomography (PET) -positive lesions with at least one lymph node lesion long diameter (LDi) \\> 1.5 cm or an extra-nodal lesion LDi \\> 1 cm (according to the Lugano classification, 2014 version)\n5. Bone marrow function was good at screening Absolute neutrophil count (ANC) ≥1×109\u002FL Platelet count ≥50×109\u002FL (no platelet transfusion \\\u003C 14 days before cycle 1 day 1, C1D1) Hemoglobin ≥8.0 g\u002FdL (no red blood cell transfusion \\\u003C 14 days before C1D1)\n6. Good liver and kidney function, namely:\n\n   AST or ALT ≤2.5× upper normal value limit (ULN), or ≤5×ULN in the presence of known lymphoma involving the liver Serum total bilirubin ≤2×ULN, or when Gilbert's syndrome or known lymphoma involves the liver≤5×ULN CrCl≥30 mL\u002Fmin according to the Cockcroft-Gault formula\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n8. Estimated life expectancy at screening was \\> 3 months\n9. Agree to use a highly effective contraceptive during the study, which lasts for 12 months after the last dose of study treatment\n\nExclusion Criteria:\n\n* Patients who met any of the following exclusion criteria were not eligible for the study:\n\n  1. Prior treatment with selinexor or another XPO1 inhibitor\n  2. There are contraindications to any drug in the combination therapy\n  3. Receipt of any standard or investigational anti-DLBCL therapy \\\u003C21 days before C1D1 (including non-palliative radiotherapy, chemotherapy, immunotherapy, radioimmunotherapy, or any other anticancer therapy) (Palliative radiotherapy for non-target lesions was allowed)\n  4. Undergone major surgery \\\u003C14 days before C1D1\n  5. Hematopoietic stem cell transplantation \u002FCAR-T therapy requirements are as follows:\n\n     Autologous hematopoietic stem cell transplantation (HSCT) \\\u003C100 days or allogeneic HSCT \\\u003C180 days prior to C1D1 Active graft-versus-host disease (GVHD) after allogeneic HSCT (or inability to discontinue GVHD therapy or preventive therapy) CAR-T cell infusion \\\u003C90 days before cycle 1\n  6. Presence of grade ≥2 neuropathy (CTCAE, v.5.0)\n  7. Presence of any life-threatening disease, medical condition, or organ system dysfunction that is considered by the investigator to be likely affecting patient safety or adherence to study procedures\n  8. Uncontrolled (i.e., clinically unstable) infection within 7 days before the first dose of study treatment and required treatment with intravenous antibiotics, antiviral drugs or antifungal drugs; However, prophylactic use of these agents was allowed.\n  9. Patients with active HBV, HCV, or HIV infection. Participants who were HBsAg positive and\u002For HBcAb positive but HBV-DNA negative, and\u002For HCV antibody positive but HCV-RNA negative were allowed to participate (the upper limit of normal values for HBV-DNA and HCV-RNA were based on the values available at each participating center).\n  10. Inability to swallow tablets, presence of a malabsorption syndrome, or any other condition that may interfere with absorption of the study drug\n  11. Lactating or pregnant women\n  12. Unable or unwilling to sign the ICF\n  13. Patients who were considered by the investigator to be significantly below tolerable weight\n  14. Patients who received live attenuated vaccine within 28 days prior to the first dose of study treatment",{"count":71,"type":20},50,[23],"To evaluate the efficacy and safety of selinexor combined with R-GDP regimen in the treatment of patients with TP53-altered relapsed or refractory B-cell lymphoma.",[26],[76,77,78,79],"TP53-altered","Relapsed\u002FRefractory","Diffuse Large B Cell Lymphoma","Selinexor","2023-11-04",{"date":82,"type":31},"2023-11-07",{"date":84,"type":20},"2023-10-30",{"date":86,"type":20},"2027-09-30",{"name":62,"class":38},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":45,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100501868","phase-4-a-study-of-secondary-infusion-of-relmacabtagene-autoleucel-injection-for-relapsed-or-refractory-b-cell-lymphoma-100501868","NCT05814848","A Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma","Inclusion Criteria:\n\n* Informed Consent Form (ICF) was obtained from the patients.\n* Diagnosed relapsed or refractory B-cell lymphomas\n\n  1. diffuse large B-cell lymphoma-not otherwise specified\n  2. diffuse large B-cell lymphoma transformed from follicular lymphoma\n  3. grade 3b follicular lymphoma\n  4. primary mediastinal large B-cell lymphoma\n  5. high-grade B-cell lymphoma with MYC and BCL-2 and\u002For BCL-6 rearrangements (double\u002Ftriple hit lymphoma)\n  6. adult follicular lymphoma refractory to second-line or later systemic therapy or relapsed within 24 months Adult patients who had completed the first treatment with remifentanil injection;\n* The patient had undergone at least one post-treatment disease assessment with Relmacabtagene Autoleucel Injection, and the investigator decided to retreat the patient (including PR\\\\PD\\\\SD) with commercially available Relmacabtagene Autoleucel injection based on clinical practice;\n* Prior to the second infusion, an adequate dose of the manufactured product (80-150x106 CAR-T cells recommended) should be confirmed, at the investigator's discretion based on the patient's condition and dose stockpile；\n* Confirmation of residual tumor tissue CD19+ in patients, if clinically permissible；\n* Absence of antidrug antibody (ADA) to ricciolenz in plasma before retreatment；\n* Toxicity associated with lymphocyte-clearing chemotherapy (fludarabine and cyclophosphamide), with the exception of alopecia, that resolved to ≤ grade 1 or returned to pre-first treatment levels before retreatment.\n* The patients did not have serious adverse reactions during the first treatment, or the adverse reactions during the first treatment had resolved to the baseline level of the first treatment.\n\nExclusion Criteria:\n\n* Patients with hypersensitivity to the active ingredient or any excipients (dimethyl sulfoxide, compound electrolyte injection, human serum albumin);\n* Patients had uncontrolled systemic fungal, bacterial, viral, or other infections",{"count":95,"type":20},13,[50],"To evaluate the efficacy and safety of post-marketing Regiorense injection secondary infusion in the treatment of adult patients with relapsed or refractory B-cell lymphoma.",[26],"2023-06-14",{"date":101,"type":31},"2023-06-15",{"date":103,"type":20},"2023-06-20",{"date":105,"type":20},"2028-03-31",{"name":107,"class":38},"Changhai Hospital"]