[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dlbcl-germinal-center-b-cell-type\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dlbcl-germinal-center-b-cell-type":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":36,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":52},"100401858","early-phase-1-iomab-act-a-pilot-study-of-131-i-apamistamab-followed-by-cd19-targeted-car-t-cell-therapy-for-patients-with-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-or-diffuse-large-b-cell-lymphoma-100401858",false,"NCT04512716","Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma","Patients with B-ALL or DLBCL (or subtypes thereof) who have relapsed or refractory disease will be eligible. Refractory disease is defined by failure to achieve at least a partial response or disease progression within 6 months of the last therapy. Patients who initially respond but subsequently demonstrate disease progression are considered to have relapsed disease\n\nParticipant Inclusion Criteria:\n\n\\- To be eligible for leukapheresis, patients must have a CD19+ B-cell malignancy with relapsed or refractory disease, defined below. To be eligible for 131-I apamistamab conditioning and treatment with 19-28z CAR T-cells, patients must additionally have detectable evidence of residual malignancy at the time of assessment prior to CAR T-cell infusion (as defined below), regardless of therapy administered following leukapheresis.\n\na. Patients with diffuse large B-cell lymphoma (de novo or DLBCL transformed from an indolent lymphoma (follicular lymphoma, chronic lymphocytic leukemia \\[Richter syndrome\\]) or high-grade B-cell lymphoma (HGBL): (\"DLBCL patients\") i. Defined as relapsed or refractory DLBCL or high-grade B-cell lymphoma (HGBL) following 2 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy) following diagnosis of de novo DLBCL\u002FHGBL or DLBCL arising from indolent lymphoma, and requiring further treatment. Exception: patients with Richter syndrome (DLBCL arising from CLL\u002Fsmall lymphocytic lymphoma) are eligible following 1 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy) and do not require a second course of chemoimmunotherapy to be eligible.\n\nii. Patients must have at least one FDG-avid (PET-avid) measurable lesion iii. Biopsy confirmation of relapsed of refractory DLBCL is required iv. For patients who have received treatment for confirmed relapsed or refractory disease otherwise meeting criteria a.i.-a.iii. as above, within 6 weeks of study enrollment, active disease does not need to be re-confirmed or present immediately prior to Screening A for the patient to be eligible for leukapheresis. However, detectable evidence of residual malignancy must be present at Screening B in order for the patient to be eligible for 131-I apamistamab and CAR T-cell therapy.\n\nb. Patients with B-cell acute lymphoblastic leukemia or B lymphoblastic lymphoma (ALL) or chronic myeloid leukemia (CML) in lymphoid blast crisis: (\"B-ALL patients\") i. Patients with Philadelphia chromosome-negative B-cell ALL must have been refractory to at least 1 line of multi-agent chemotherapy or relapsed following at least 1 prior multiagent systemic chemotherapy regimen that included induction and consolidation therapy ii. Patients with Philadelphia chromosome-positive ALL or CML in lymphoid blast crisis must have exhibited persistent disease following therapy with a second- or third-generation tyrosine kinase inhibitor iii. Patients must have ≥5% bone marrow involvement and\u002For at least one FDG-avid (PET-avid) measurable extramedullary lesion iv. For patients who have received treatment for confirmed relapsed or refractory disease otherwise meeting criteria b.i.-b.iii. as above, within 6 weeks of study enrollment, active disease does not need to be re-confirmed or present immediately prior to Screening A for the patient to be eligible for leukapheresis. However, detectable evidence of residual malignancy must be present at Screening B in order for the patient to be eligible for 131-I apamistamab and CAR T-cell therapy.\n\n* While prior CD19-targeted therapies, including CAR T-cell therapy, do not exclude participation, CD19 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment.\n* Age ≥ 18 years of age\n* Creatinine clearance ≥50 mL\u002Fmin as calculated by the Cockroft-Gault formula\n* Direct bilirubin ≤2.0 mg\u002FdL, AST and ALT ≤3.0x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy\n* Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.\n* Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the past 7 days, unless cytopenias are attributed to underlying malignancy in the opinion of the investigator:\n\n  1. Absolute neutrophil count ≥0.5k\u002FµL,\n  2. Platelets ≥30k\u002FµL,\n  3. Hemoglobin ≥7g\u002FdL.\n* ECOG performance status 0-2.\n\nParticipant Exclusion Criteria:\n\n* ECOG performance status ≥3.\n* Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.\n* Impaired cardiac function (LVEF \\\u003C40%) as assessed by echocardiogram or MUGA scan during screening\n* Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible\n* Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible\n* Patients with following cardiac conditions will be excluded:\n\n  1. New York Heart Association (NYHA) stage III or IV congestive heart failure\n  2. Myocardial infarction ≤6 months prior to enrollment\n  3. Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n  4. Any history of severe non-ischemic cardiomyopathy with LVEF ≤20%\n* Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:\n\n  1. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded.\n  2. Subjects who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded.\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible.\n* Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.\n* Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.\n* Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.\n* Patients with circulating human anti-mouse antibodies to BC8 noted on initial screening (see Appendix III)\n\nSubject Inclusion Criteria for 131-I Apamistamab Infusion Patients should meet performance status and organ function parameters as specified, without known development of an exclusion criterion, prior to proceeding to 131-I apamistamab infusion. See Section 9.2 re: screening for treatment.","ALL","18 Years",{"count":18,"type":19},12,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.",[25,26,27,28,29,30,31,32,33,34,35],"B-ALL","DLBCL","B ALL","Dlbcl-Ci","DLBCL Unclassifiable","DLBCL, Nos Genetic Subtypes","DLBCL Activated B-Cell Type","DLBCL Germinal Center B-Cell Type","Diffuse Large B-cell Lymphoma","HGBL","HGBL, Nos",[37,38,39,40],"CD19+ B-cell malignancy","131-I apamistamab","B-cell malignancy","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-02-13",{"date":44,"type":45},"2026-02-17","ACTUAL",{"date":47,"type":45},"2021-02-02",{"date":49,"type":19},"2027-01",{"name":40,"class":51},"OTHER",7,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":20,"phases":62,"briefSummary":64,"conditions":65,"keywords":90,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"100481055","phase-1-study-of-sgr-1505-in-mature-b-cell-neoplasms-100481055","NCT05544019","Study of SGR-1505 in Mature B-Cell Neoplasms","A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies","Inclusion Criteria:\n\n* Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.\n* Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).\n* Subject has previous invasive malignancy in the last 2 years.\n* Subject has a known allergy to SGR-1505 or excipients of SGR-1505.\n* Subject has symptomatic or active CNS involvement of disease.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.",{"count":61,"type":19},98,[63],"PHASE1","The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and\u002For recommended dose (RD) of SGR-1505.",[66,67,26,68,69,70,71,72,73,74,75,76,77,78,79,32,80,81,82,83,84,85,86,87,88,89],"Mature B-Cell Neoplasm","Non Hodgkin Lymphoma","Waldenstrom Macroglobulinemia","MALT Lymphoma","Follicular Lymphoma","Pediatric-Type Follicular Lymphoma","IRF4 Gene Rearrangement","EBV-Positive DLBCL, Nos","Burkitt Lymphoma","Plasmablastic Lymphoma","High-grade B-cell Lymphoma","Primary Cutaneous Follicle Center Lymphoma","Primary Effusion Lymphoma","Mantle Cell Lymphoma","Primary Mediastinal Large B Cell Lymphoma","T-Cell\u002FHistiocyte Rich Lymphoma","ALK-Positive Large B-Cell Lymphoma","Primary Cutaneous Diffuse Large B-Cell Lymphoma","Splenic Marginal Zone Lymphoma","Chronic Lymphocytic Leukemia","Nodal Marginal Zone Lymphoma","HHV8-Positive DLBCL, Nos","Lymphoplasmacytic Lymphoma","Duodenal-Type Follicular Lymphoma",[91,92,68],"MALT1","NF-kB","2026-02-11",{"date":42,"type":45},{"date":96,"type":45},"2023-04-10",{"date":98,"type":19},"2027-11",{"name":100,"class":101},"Schrödinger, Inc.","INDUSTRY",36,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":20,"phases":113,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100471683","phase-2-selinexor-plus-r-chop-in-high-risk-gcb-subtype-diffuse-large-b-cell-lymphoma-100471683","NCT05422066","Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma","Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:\n\n  1. Willing and able to written informed consent (ICF) .\n  2. Age ≥ 18 years and ≤ 75 years.\n  3. Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.\n  4. Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.\n  5. International Prognostic Index score of 3-5.\n  6. Computed Tomography(CT)\u002FPositron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than \\> 1.5cm or 1 extranodal lesion with LDi \\>1 cm.\n  7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n  8. Adequate bone marrow function at Screening(Except for underlying diseases, such as secondary hypersplenism due to bone marrow invasion or splenic invasion identified by the investigator).\n\n     1. Absolute neutrophil count (ANC)≥1.5×109\u002FL;\n     2. Platelet count (PLT) ≥100×109\u002FL(no platelet transfusion within 14 days prior to C1D1), or PLT≥ 75×109\u002FL if due to lymphoma with bone marrow involvement.\n     3. Hemoglobin (HB)≥85g\u002FL(no red blood cell transfusion within 14 days prior to C1D1).\n  9. Adequate hepatic and renal function:\n\n     1. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or AST and ALT≤5.0 x ULN(if due to lymphoma involvement),\n     2. Serum total bilirubin ≤2×ULN, or Serum total bilirubin ≤5×ULN if due to Gilbert syndrome or lymphoma involvement.\n     3. Estimated creatinine clearance ≥ 30 mL\u002Fmin (calculated using the formula of Cockroft-Gault).\n  10. Participants of childearing potential must agree to use highly effective methods of contraception during the duration of the study and following the last dose of study treatment, female and male participants should continue contraception for 14 and 11 months, respectively.\n\n      1. Female participants of childbearing potential must have a negative serum pregnancy test at screening(Non-Childbearing potential: Age \\>50 years and naturally amenorrhoeic for \\>1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\n      2. Male participants must agree to avoid sperm donation during the duration of the study and 14 months following the last dose of study treatment.\n\nExclusion Criteria:\n\n* Inclusion\u002FExclusion Criteria:\n\nInclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be eligible to enroll in this study:\n\n1. Willing and able to written informed consent (ICF) .\n2. Age ≥ 18 years and ≤ 75 years.\n3. Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.\n4. Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.\n5. International Prognostic Index score of 3-5.\n6. Computed Tomography(CT)\u002FPositron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than \\> 1.5cm or 1 extranodal lesion with LDi \\>1 cm.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n8. Adequate bone marrow function at Screening(Except for underlying diseases, such as secondary hypersplenism due to bone marrow invasion or splenic invasion identified by the investigator).\n\n   1. Absolute neutrophil count (ANC)≥1.5×109\u002FL;\n   2. Platelet count (PLT) ≥100×109\u002FL(no platelet transfusion within 14 days prior to C1D1), or PLT≥ 75×109\u002FL if due to lymphoma with bone marrow involvement.\n   3. Hemoglobin (HB)≥85g\u002FL(no red blood cell transfusion within 14 days prior to C1D1).\n9. Adequate hepatic and renal function:\n\n   1. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or AST and ALT≤5.0 x ULN(if due to lymphoma involvement),\n   2. Serum total bilirubin ≤2×ULN, or Serum total bilirubin ≤5×ULN if due to Gilbert syndrome or lymphoma involvement.\n   3. Estimated creatinine clearance ≥ 30 mL\u002Fmin (calculated using the formula of Cockroft-Gault).\n10. Participants of childearing potential must agree to use highly effective methods of contraception during the duration of the study and following the last dose of study treatment, female and male participants should continue contraception for 14 and 11 months, respectively.\n\n    1. Female participants of childbearing potential must have a negative serum pregnancy test at screening(Non-Childbearing potential: Age \\>50 years and naturally amenorrhoeic for \\>1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\n    2. Male participants must agree to avoid sperm donation during the duration of the study and 14 months following the last dose of study treatment.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not be enrolled:\n\n1. DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma; composite lymphoma (Hodgkin lymphoma + NHL); Gray zone lymphoma; DLBCL transformed from Chronic Lymphocytic Leukemia (Richter Syndrome); Primary mediastinal large B-cell lymphoma (PMBCL); T-cell rich large B-cell lymphoma.\n2. Known active central nervous system lymphoma or meningeal involvement at screening. Participants with a history of CNS disease treated into remission may be enrolled. The DLBCL of Testis involvement or more than two extranodal involvement.\n3. Previous treatment with selinexor or other XPO1 inhibitors.\n4. Contraindication to any drug contained in these regimen.\n5. Major surgery \\\u003C14 days of C1D1, Except for disease diagnosis.\n6. Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, or able to comply with the study procedures.\n7. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).\n8. Subjects with known active Hepatitis B (HB) infection, active Hepatitis C (HCV) infection or Human Immunodeficiency Virus (HIV) positivity. Participants with active hepatitis B Virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for \\>8 weeks and viral load is \\\u003C100 international units per milliliter (IU\u002FmL); participants with untreated hepatitis C Virus (HCV) are eligible if viral load is negative per institutional standard; participants with human immunodeficiency virus (HIV) are eligible if cluster of differentiation 4 (CD4+) T-cell counts ≥350 cells per microliter (cells\u002FμL), viral load is negative and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year.\n9. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).\n10. Breastfeeding women or pregnant women.\n11. In the opinion of the Investigator, participants who are below their ideal body weight and would be unduly impacted by changes in their weight.\n12. Life expectancy of less than 6 months.","75 Years",{"count":112,"type":19},50,[114],"PHASE2","This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment\u002Ffollow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.",[32],[118,119,120,26,121],"Selinexor","Xpovio","Newly Diagnosed","IPI 3-5","2024-06-14",{"date":124,"type":45},"2024-06-17",{"date":126,"type":45},"2022-07-26",{"date":128,"type":19},"2025-12-31",{"name":130,"class":51},"Li Zhiming",6]