[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-primary-mediastinal-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-primary-mediastinal-large-b-cell-lymphoma":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,54,79,106,128,170],{"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":25,"conditions":26,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100557279","phase-1-epcoritamab-plus-ibrutinib-for-the-treatment-of-relapsed-or-refractory-aggressive-b-cell-non-hodgkin-lymphoma-100557279",false,"NCT06536049","Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma","Phase Ib\u002FII Trial of Epcoritamab Plus Ibrutinib in Patients With Relapsed\u002FRefractory Aggressive B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* One of the following CD20+ B-cell non-Hodgkin lymphoma subtypes (note, documentation of CD20 positivity by flow cytometry and\u002For immunohistochemistry is based on any representative pathology report)\n\n  * Diffuse large B-cell lymphoma (DLBCL), including DLBCL, not otherwise specified (NOS); T-cell\u002Fhistiocyte-rich large B-cell lymphoma; and Epstein-Barr virus-positive DLBCL, NOS\n  * High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and\u002For BCL6 rearrangements (double-hit or triple-hit lymphoma) or HGBL, NOS\n  * Primary mediastinal B-cell lymphoma (PMBCL)\n  * Follicular lymphoma, grade 3b (also known as follicular large B-cell lymphoma in the 5th edition of World Health Organization \\[WHO\\] classification of lymphoid neoplasms)\n  * Patients with previously diagnosed indolent lymphoma (follicular lymphoma or marginal zone lymphoma but not lymphoplasmacytic lymphoma or small lymphocytic lymphoma\u002Fchronic lymphocytic leukemia) who have transformed to any of the above lymphoma subtypes are eligible\n* Patients must have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody:\n\n  * ≥ 2 prior systemic lymphoma treatments OR\n  * ≥ 1 prior systemic lymphoma treatment in patients with high-risk disease defined as primary refractory or relapsed within 12 months of completing anthracycline-based frontline treatment who are ineligible for chimeric antigen receptor (CAR) T cells per the treating physician. The reason for CAR T-cell treatment ineligibility should be documented\n  * Prior treatment with a BTK inhibitor is allowed if stopped due to lymphoma progression or treatment completion but not intolerance\n  * Prior treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days prior to enrollment\n  * Prior treatment with CAR T cells is allowed if ≥ 30 days prior to enrollment\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ibrutinib or epcoritamab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Measurable disease (defined as \\> 1.5 cm in diameter) or at least one PET fludeoxyglucose F-18 (FDG) avid area of disease\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FmcL\n* Platelet count ≥ 75,000\u002FmcL. Platelet count ≥ 50,000\u002FmcL is allowed in case of bone marrow involvement and\u002For splenomegaly\n* Hemoglobin ≥ 8 g\u002FdL\n* Transfusion and\u002For growth factor support within 7 days (or 14 days in case of long-acting growth factors such as pegylated granulocyte colony-stimulating factor \\[G-CSF\\]) of enrollment to meet these requirements is not permitted\n* Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN) (unless due to Gilbert's disease or hemolysis in which case bilirubin must be \\\u003C 3 x ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \\\u003C 3 x institutional ULN\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) \\\u003C 3 x institutional ULN\n* Creatinine clearance \\> 45 mL\u002Fmin calculated by Cockcroft-Gault. Patients on dialysis are not eligible\n* The effects of ibrutinib and epcoritamab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 2 weeks before initiation of treatment, for the duration of study participation and for 12 months after completing treatment. Should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men must agree to refrain from sperm donation for at least 12 months after the last dose of epcoritamab\n* Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \\[β-hCG\\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study\n* Patients must have the ability to understand and the willingness to sign a written informed consent document and Health Insurance Portability and Accountability Act (HIPAA) consent document. Voluntary written consent must be given before the performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care\n\nExclusion Criteria:\n\n* Prior therapy with a bispecific antibody targeting CD3 and CD20\n* Prior lymphoma therapy should be completed greater than two weeks before the start of protocol therapy, except for corticosteroids used for palliation of symptoms\n* Patients who require immediate cytoreductive therapy for their lymphoma per the treating physician's assessment are ineligible\n* Patients with a history of allogeneic stem cell transplantation are excluded unless the transplant was \\> 180 days before the first scheduled dose of ibrutinib AND the patient does not have evidence of active acute or chronic graft versus host disease AND the patient must not have taken immunosuppressive medications associated with the transplant for at least 1 month before the first scheduled dose of ibrutinib\n* Ongoing systemic treatment with a strong CYP3A inhibitor or inducer. Treatment with any strong CYP3A inhibitor or inducer needs to be stopped for 5 half-lives prior to starting treatment on trial\n* Major surgery within 4 weeks before the start of treatment other than surgery performed for lymphoma diagnosis\n* Known active central nervous system (CNS) involvement by lymphoma. Patients who are enrolled and subsequently identified to have pathologic confirmation of CNS involvement by lymphoma may be continued on the study at the discretion of the principal investigator\n* Active uncontrolled infection or infection requiring intravenous (IV) antibiotic therapy for \\> 2 consecutive days within 2 weeks prior to the first dose of study drug\n* Evidence of current uncontrolled or symptomatic cardiovascular conditions, including, uncontrolled cardiac arrhythmias, history of or symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or greater), unstable angina, or myocardial infarction within the past 6 months. Poorly controlled or clinically significant atherosclerotic vascular disease including angioplasty, cardiac or vascular stenting within 6 months of enrollment\n* Known liver cirrhosis with moderate to severe hepatic impairment (Child-Pugh class B or C)\n* Clinically significant pulmonary disease or history of bronchospasm requiring intubation, or clinically significant active interstitial lung disease or pneumonitis\n* History of cerebrovascular accident or transient ischemic attack within the 6 months before day 1, cycle 1 of treatment\n* Any prior history of intracranial hemorrhage\n* Clinically significant known bleeding diatheses or platelet dysfunction disorders.\n* Receiving treatment with coumadin\u002Fwarfarin\n* Known gastrointestinal disease or gastrointestinal procedure that will significantly interfere with the oral absorption or tolerance of ibrutinib including the inability to swallow pills\u002Fcapsules\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n* Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent\n* Prior solid organ transplant\n* History of other malignancies that could affect compliance with the protocol or interpretation of results in the opinion of the investigator\n* Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 21 days of the first scheduled dose of ibrutinib (cycle 1 day -7)\n* Known history of HIV, active hepatitis C infection (HCV ribonucleic acid \\[RNA\\] polymerase chain reaction \\[PCR\\]-positive) and\u002For active hepatitis B infections (HBV DNA PCR-positive). If hepatitis B core (HBc) antibody is positive, the patient must be evaluated for the presence of HBV DNA by PCR. If HCV antibody is positive, the patient must be evaluated for the presence of HCV RNA by PCR. Patients with positive HBc antibody and negative HBV DNA by PCR are eligible. Patients with positive HCV antibody and negative HCV RNA by PCR are eligible\n* Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with ibrutinib or epcoritamab, breastfeeding should be discontinued if the mother is treated with ibrutinib or epcoritamab\n* Patients with ongoing clinically significant grade ≥ 2 toxicity from prior therapy","ALL","18 Years",{"count":19,"type":20},38,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase Ib\u002FII trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and\u002For more effective.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Grade 3b Follicular Lymphoma","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent Primary Mediastinal Large B-Cell Lymphoma","Recurrent Transformed Non-Hodgkin Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Grade 3b Follicular Lymphoma","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified","Refractory Primary Mediastinal Large B-Cell Lymphoma","Refractory Transformed Non-Hodgkin Lymphoma","RECRUITING","2026-06-02",{"date":44,"type":45},"2026-06-04","ACTUAL",{"date":47,"type":45},"2025-04-02",{"date":49,"type":20},"2027-10-31",{"name":51,"class":52},"Yazeed Sawalha","OTHER",2,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100536917","phase-2-golcadomide-post-car-t-cell-in-rr-aggressive-large-b-cell-lymphoma-patients-with-high-risk-of-relapse-100536917","NCT06271057","Golcadomide Post-CAR T-cell in R\u002FR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse","Golcadomide (BMS-986369) Post-CAR T-cell in R\u002FR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse","Inclusion Criteria:\n\n1. Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments\u002Fprocedures being conducted\n2. Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)\n3. Eligible for any commercialized market authorized anti-CD19 CAR T-cells\n4. Performance Status 0, 1, or 2\n5. With aggressive large B-cell lymphoma, including:\n\n   * diffuse large B-cell lymphoma\n   * Primary mediastinal B-cell lymphoma\n   * Any transformed follicular or marginal zone lymphoma\n   * high-grade B-cell lymphoma (HGBL) Note: patients with Central Nervous System (CNS) involvement could be included but not patients with primary CNS lymphoma\n6. Available biopsy for centralized review\n7. With a CAR T-cells indication as soon as 2nd line treatment no later than in 4th line, previously validated by the multidisciplinary tumor board Note: Any treatment performed prior to leukapheresis is considered a line of treatment\n8. Total MetabolicTumor Volume (TMTV) \\> 80 ml, measured by centralized review, on standard18FDG-PET (positron emission tomography) done just before starting CAR T-cells procedure (i.e., D-13 +\u002F- 4 days before lymphodepletion)\n9. Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD) if \\> 60-year-old or Cockcroft-Gault if \\\u003C60yo) \\>45 mL\u002Fmin,\n10. Adequate hepatic function:\n\n    * aspartate aminotransferase\u002Falanine aminotransferase (ALT\u002FAST) ≤ 3.0 x ULN. (Note: In the case of documented liver involvement by lymphoma, ALT\u002FAST must be ≤ 5.0 x ULN)\n    * Serum total bilirubin ≤ 2.0 mg\u002FdL (34 μmol\u002FL) (Note: In the case of Gilbert's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be ≤ 3.0 mg\u002FdL (51 μmol\u002FL))\n11. Patient covered by any social security system (France)\n12. Patient who understands and speaks one of the country official languages, unless local regulation authorizes independent translators\n13. Contraception:\n\n    * For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method, as soon as consent is signed, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, Women must refrain from donating eggs during this same period.\n\nExclusion Criteria:\n\n1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years\n2. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor\n3. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines\n4. Significant pulmonary function impairment and oxygen saturation (SaO2) \\\u003C 92% on room air\n5. Significant cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease (see appendix 07)\n6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study\n8. Current treatment with strong CYP3A4\u002F5 modulators (see appendix 13)\n9. Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential\n10. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)\n11. Person deprived of his\u002Fher liberty by a judicial or administrative decision\n12. Person hospitalized without consent\n13. Adult person under legal protection",{"count":62,"type":20},65,[24],"This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.\n\nApproximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.\n\nThe duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.\n\nThe primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.",[66,39,67,68],"Diffuse Large B-cell Lymphoma Refractory","Refractory Transformed B-cell Non-Hodgkin Lymphoma","Refractory High Grade B-Cell Lymphoma",[70],"eligible for CAR T-cells therapy",{"date":44,"type":45},{"date":73,"type":45},"2024-06-14",{"date":75,"type":20},"2028-12-31",{"name":77,"class":52},"The Lymphoma Academic Research Organisation",13,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100576394","phase-2-odronextamab-for-relapsed-and-refractory-large-b-cell-lymphomas-before-car-t-100576394","NCT06784726","Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T","Odronextamab for Relapsed\u002FRefractory Large B-Cell Lymphomas Before Definitive Lymphoma-Directed Therapies","Inclusion Criteria:\n\n* Histologically confirmed large B cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, DLBCL arising from indolent lymphoma, follicular lymphoma (FL) grade 3B\n* Measurable disease, defined as at least one measurable lesion ≥ 15 mm on PET, CT, or magnetic resonance imaging (MRI) within one month of screening, according to the International Working Group consensus response evaluation criteria in lymphoma\n* Prior frontline therapy for large B cell lymphoma must have failed the patient, and criteria must be met for receiving commercial axicabtagene ciloleucel (axi-cel), lisocabtagene maraleucel (liso-cel), or tisagenlecleucel (tisa-cel) per Food and Drug Administration (FDA) label\n* Age ≥ 18 years\n* Capable of understanding and providing a written informed consent\n* Prior treatment with an anti-CD20 antibody therapy\n* Eastern Cooperative Oncology Group performance status of 0-1; we allow enrollment of patients with a performance status of 2 if it is attributed to lymphoma per discretion of the treating physician or principal investigator (PI)\n* Creatinine clearance ≥ 45 mL\u002Fmin calculated by Cockcroft-Gault equation\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome\n* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x the ULN\n* Adequate pulmonary function, defined as ≤ grade 1 dyspnea and oxygen saturation (SpO2) ≥ 92% on room air\n* Adequate cardiac function, defined as left ventricular ejection fraction ≥ 50% and without evidence for pericardial effusion\n* Platelet count ≥ 75 x 10\\^9 \u002FL\n* Hemoglobin (Hg) level ≥ 9 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1 x 10\\^9 \u002FL\n* Patients with bone marrow involvement or splenic sequestration: Platelet count ≥ 25 x 10\\^9 \u002FL\n* Patients with bone marrow involvement or splenic sequestration: Hg ≥ 7.0 g\u002FdL\n* Patients with bone marrow involvement or splenic sequestration: ANC ≥ 0.5 x 10\\^9 \u002FL\n* Negative serum pregnancy test within 2 days of initiating odronextamab for women of childbearing potential (WOCBP), defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year\n* Fertile male and WOCBP patients must be willing to use highly effective contraceptive methods from study recruitment to at least 6 months after the CAR T-cell infusion\n* Patients must not provide egg or sperm donation until at least 6 months after the completion of the last dose of Odron\n\nExclusion Criteria:\n\n* Detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases. Patients with a history of secondary central nervous system (CNS) lymphoma may be eligible provided that there has been no evidence of CNS disease from lymphoma for at least 3 months at the time of screening\n* History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement\n* Standard anti-neoplastic chemotherapy (non-biologic) within 5-times the half-life or within 2 weeks, whichever is shorter, prior to first administration of study drug\n* Standard radiotherapy within 2 weeks of first administration of study drug\n* Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy, unless all the following are met: disease responded to prior bispecific therapy (CR or PR per Lugano criteria) and did not experience disease progression within 12 months of the last dose of prior bispecific therapy, and the tumor must still express CD20 (CD20 examination per standard of care \\[SOC\\])\n* Allogeneic stem cell transplantation\n* Any CAR-T cell therapy\n* Patients may not be receiving other investigational agents\n* Treatment with rituximab, alemtuzumab, or other investigational or commercial biologic agent within 2 weeks prior to first administration of study drug\n* Immunosuppressive therapy (other than biologic) within 2 weeks of first administration of study drug\n* Treatment with an investigational non-biologic agent within 2 weeks of first administration of study drug\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition of study drug\n* History of hypersensitivity to any compound in the tetracycline antibiotics group\n* Concurrent active malignancy for which the patient is receiving systemic treatment, unless approved by PI\n* Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection\n* Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) and\u002For significant pulmonary disease (e.g., obstructive pulmonary disease and history of symptomatic bronchospasm)\n* Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg\u002Fday of prednisone or equivalent. A short course of corticosteroid for lymphoma disease control during screening is allowed\n* Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 400) or chronic infection with hepatitis B virus or hepatitis C virus. Patients with hepatitis B (hepatitis B surface antigen positive \\[HepBsAg+\\]) with controlled infection were permitted upon consultation with the physician managing the infection\n* Known hypersensitivity to both allopurinol and rasburicase\n* Pregnant or breast-feeding women\n* Administration of live vaccination within 28 days of first administration of study drug",{"count":87,"type":20},27,[24],"This phase II trial tests the effectiveness of odronextamab given before chimeric antigen receptor T (CAR-T) cell therapy (bridging therapy) in patients with large B-cell lymphomas that have come back after a period of improvement (relapsed) or that have not responded to previous treatment (refractory). Odronextamab is a bispecific antibody that can bind to two different antigens at the same time. Odronextamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Bridging therapy has been used to maintain disease control and to increase the chance of successful receipt of CAR-T cell therapy. However, bridging therapy is typically given after leukapheresis, which does not help prevent disease progression between the decision for CAR-T cell therapy and leukapheresis. Giving odronextamab as bridging therapy before leukapheresis may delay disease progression to allow leukapheresis and increase the likelihood of successful CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphomas.",[27,91,28,92,32,93,34,94,35,68,39,95],"Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Recurrent High Grade B-Cell Lymphoma","Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2026-05-04",{"date":98,"type":45},"2026-05-06",{"date":100,"type":45},"2025-09-04",{"date":102,"type":20},"2033-04-11",{"name":104,"class":52},"University of Washington",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100621029","phase-2-epcoritamab-rituximab-gemcitabine-and-oxaliplatin-r-gemox-as-salvage-therapy-before-autologous-stem-cell-transplant-for-the-treatment-of-relapsedrefractory-diffuse-large-b-cell-lymphoma-100621029","NCT07365306","Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed\u002FRefractory Transplant-Eligible DLBCL","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed diagnosis of DLBCL, not-otherwise specified (NOS), transformation of indolent B-cell lymphoma, High grade B-cell lymphoma (HGBCL), NOS, primary mediastinal large B-cell lymphoma (PMBCL)\n* Biopsy-proven relapsed or refractory disease after 1 prior line of chemoimmunotherapy and:\n\n  * CAR-naïve patients (Cohort 1)\n\n    * If primary refractory, or relapsed within 12 months and are ineligible for or are unwilling to undergo CD19-directed CAR-T cell therapy\n    * If relapsed beyond 12 months\n  * CAR-experienced patients (Cohort 2)\n\n    * If relapsed or refractory to CD19-directed CAR T cell therapy\n* Measurable disease on computed tomography (CT) scan, defined as a nodal site greater than 1.5 cm in the longest axis or an extranodal site greater than 1.0 cm in the longest axis AND baseline fluorodeoxyglucose-positron emission tomography (FDG-PET) must demonstrate positive lesion compatible with CT defined anatomical tumor sites\n* Considered eligible for high-dose chemotherapy followed by ASCT\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Positive for CD20 by immunohistochemistry\n* Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Without bone marrow involvement: Platelets ≥ 100,000\u002Fmm\\^3. With bone marrow involvement: Platelets ≥ 75,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 8g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN)\n\n  * If hepatic involvement by lymphoma, or Gilbert's disease: ≤ 3 X ULN\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (AST) ≤ 3.0 x ULN\n* Creatinine clearance of ≥ 45 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants\n* Seronegative for HIV antigen\u002Fantibody (Ag\u002FAb) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n\nHIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of study therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual intercourse for the course of the study and after completion of study treatment as described below separately for males and females.\n\n  * Female participants must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the last dose of gemcitabine, 9 months after the last dose of oxaliplatin, and 12 months after the last dose of rituximab, 12 months after the final dose of epcoritamab and 3 months after the final dose of tocilizumab (as applicable), whichever is longer. Women must refrain from donating eggs during this same period.\n\n    * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n    * Hormonal contraceptive methods must be supplemented by a barrier method.\n  * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, as defined below:\n\n    * With a female partner of childbearing potential or pregnant female partners, male participants must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 12 months after the last dose of epcoritamab, 6 months after the last dose of oxaliplatin, 3 months after the last dose of gemcitabine, 12 months after the last dose of rituximab, or 2 months after the last dose of tocilizumab (as applicable), whichever is longer. Male participants must refrain from donating sperm during this same period.\n    * If a female partner becomes pregnant or suspects becoming pregnant during treatment or within 12 months after the last dose of the trial intervention, the Investigator must be informed immediately. The Investigator may want to follow the pregnancy and may ask the female partner to sign a consent form so the Investigator or designee can collect information about the outcome of the pregnancy.\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 individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n  * Childbearing potential defined as not being permanently surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only). Per this definition, a female participant with tubal ligation is considered to be of childbearing potential.\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* CONSOLIDATION WITH EPCORITAMAB: Achieved objective response per 2014 Lugano Classification at end of salvage\n* CONSOLIDATION WITH EPCORITAMAB: Absence of unrelated toxicity not present at baseline that might adversely affect participation\u002F administration of epcoritamab\n* CONSOLIDATION WITH EPCORITAMAB: Recovered from ASCT toxicities in patients who received ASCT. Including: outpatient status, able to drink and eat normally, and do not need intravenous hydration prior to cycle 1 day 1 of consolidation therapy\n* CONSOLIDATION WITH EPCORITAMAB: Will initiate treatment between day +30 and day +60 post-ASCT or post end of salvage therapy in those with CR\u002FPR but do not proceed to ASCT\n* CONSOLIDATION WITH EPCORITAMAB: ECOG ≤ 2 within the screening period\n* CONSOLIDATION WITH EPCORITAMAB: ANC ≥ 1,000\u002Fmm\\^3 within 14 days prior to day 1 of consolidation\n* CONSOLIDATION WITH EPCORITAMAB: Platelets ≥ 75,000\u002Fmm\\^3 within 14 days prior to day 1 of consolidation\n* CONSOLIDATION WITH EPCORITAMAB: Total serum bilirubin ≤ 1.5X upper limit of normal (ULN), OR if Gilbert's disease: ≤ 3X ULN, within 14 days prior to day 1 of consolidation\n* CONSOLIDATION WITH EPCORITAMAB: AST ≤ 2.5 x ULN, OR if hepatic involvement by lymphoma: AST ≤ 5 x ULN, within 14 days prior to day 1 of consolidation\n* CONSOLIDATION WITH EPCORITAMAB: ALT ≤ 2.5 x ULN, OR If hepatic involvement by lymphoma: ALT ≤ 5 x ULN, within 14 days prior to day 1 of consolidation\n* CONSOLIDATION WITH EPCORITAMAB: Creatinine clearance of ≥ 40 mL\u002Fmin within 14 days prior to day 1 of consolidation\n* CONSOLIDATION WITH EPCORITAMAB: No active ≥ grade 3 infection within 14 days prior to day 1 of consolidation\n* CONSOLIDATION WITH EPCORITAMAB: No other active malignancy requiring therapy. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer\n* CONSOLIDATION WITH EPCORITAMAB: No symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), cerebrovascular event\u002Fstroke or myocardial infarction within the last 6 months\n* CONSOLIDATION WITH EPCORITAMAB: No central nervous system involvement by lymphoma, including leptomeningeal involvement\n* CONSOLIDATION WITH EPCORITAMAB: No history of or current progressive multifocal leukoencephalopathy (PML)\n\nExclusion Criteria:\n\n* Autologous or allogeneic stem cell transplant within 1 year prior to day 1 of study therapy\n* Chemotherapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of study therapy other than a single cycle of R-GemOx\n* Has received or plans to receive radiotherapy except for palliative radiation to non-target lesions or major surgery within 4 weeks prior day 1 of study therapy\n* Prior solid organ transplantation\n* Vaccination with live vaccines within 4 weeks of the first dose of study drug or is expected to need any live vaccination during study participation including at least 3 months following the last dose of study treatment.\n\n  * COVID-19 non-replicating adenoviral vaccines are permitted with a minimum period of 3 days between the vaccine and a dose of study treatment\n* Active medication use known to decrease T-cell numbers or activity or other concurrent immunosuppressive medication within 5 half-lives or 28 days, whichever is longer, prior to randomization except for up to 20 mg prednisone daily or equivalent\n* Known active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement\n* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia, or New York Heart Association (NYHA) heart failure class III-IV, or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months of screening\n* Clinically significant liver disease, including active hepatitis, current alcohol abuse, or cirrhosis\n* History of severe allergic or anaphylactic reactions to anti CD20 monoclonal or bi-specific antibody therapy, or known significant allergy or intolerance to any component or excipient constituents of the study treatment (and their excipients) and\u002For other products in the same class\n* Clinically significant uncontrolled illness\n* Active uncontrolled infection requiring systemic antibiotics\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) within 2 weeks prior to first dose of study treatment\n* Current seizure disorder requiring therapy\n* Peripheral (sensory) neuropathy grade \\> 1 with the exception of neuropathy related directly to lymphoma (e.g., nerve compression from tumor)\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Recent major surgery (within 4 weeks) prior to start of study therapy, other than for diagnosis\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with past HBV infection (defined as negative HBV surface antigen \\[HBsAg\\] and positive hepatitis B core antibody \\[HBcAb\\]) are eligible if HBV DNA is undetectable. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). Testing to be done only in patients suspected of having infections or exposures\n* Known active human immunodeficiency virus (HIV) infection. Subjects who have an undetectable or unquantifiable HIV viral load with CD4 \\> 200 and are on highly active antiretroviral therapy (HAART) medication are allowed. Testing to be done only in patients suspected of having infections or exposures\n* Active (symptomatic) cytomegalovirus (CMV) disease\n* Active tuberculosis (TB) or history of completed treatment for active TB within the past 12 months\n* History of or current progressive multifocal leukoencephalopathy (PML)\n* Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) grade 0 or 1, with the exception of alopecia\n* Females only: Pregnant or breastfeeding\n* Unable to tolerate SC injections\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":114,"type":20},43,[24],"This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.",[91,31,32,93,94,38,39,95],"2026-04-21",{"date":120,"type":45},"2026-04-24",{"date":122,"type":45},"2026-04-15",{"date":124,"type":20},"2029-10-15",{"name":126,"class":52},"City of Hope Medical Center",3,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100580213","phase-2-golcadomide-and-rituximab-as-bridging-therapy-for-relapsed-or-refractory-aggressive-b-cell-non-hodgkin-lymphoma-before-car-t-cell-therapy-100580213","NCT06834373","Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy","Phase 2 Study of Golcadomide With Rituximab as a Bridging Therapy Prior to CAR-T for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (NHL)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed pathology diagnosis according to 2016 World Health Organization (WHO) classification including patients with diseases listed below with relapsed, progressive and\u002For refractory disease (Cheson et al. 2014) following treatment with one or two prior lines of standard therapy, no more than two lines of therapy are permitted:\n\n  * Diffuse large B-cell lymphoma not otherwise specified (NOS) including:\n\n    * Transformed lymphoma\n    * Germinal center B-cell type\n    * Activated B-cell type\n  * High-grade B-cell lymphoma (HGBCL), NOS\n  * High grade B-cell lymphoma with MYC and BCL2 translocation\n  * Primary mediastinal (thymic) large B-cell lymphoma\n  * Grade 3B follicular lymphoma\n  * T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n  * Large B-cell lymphoma with IRF4 rearrangement\n  * Primary cutaneous diffuse large B-cell lymphoma (DLBCL), leg type\n  * Epstein-Barr virus (EBV) positive DLBCL, NOS\n  * DLBCL associated with chronic inflammation\n  * Intravascular large B-cell lymphoma\n  * ALK positive large B-cell lymphoma\n  * NOTE: Richters transformation patients are excluded\n* Measurable disease by PET-CT with at least one lymph node or other type of lesion that has a size \\> 1.5 cm in the transverse diameter, as defined by Lugano classification\n\n  * NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible\n* Patient is potentially eligible for CAR-T therapy as determined by treating physician\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Hemoglobin \\> 7.0 g\u002FdL (obtained ≤ 14 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1000\u002FmcL (obtained ≤ 14 days prior to registration); growth factor support allowed at physician discretion\n* Platelet count ≥ 75,000\u002FmcL (obtained ≤ 14 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration); if total bilirubin is \\> 1.5 ULN, direct bilirubin must be normal\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN (≤ 5 x ULN if there is evidence of parenchymal liver involvement with lymphoma) (obtained ≤ 14 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* Have 2 negative pregnancy tests as verified by the investigator prior to starting CC-99282:\n\n  * A negative serum pregnancy test (sensitivity of at least 25 mIU\u002FmL) at screening (between 10 to 14 days prior to cycle 1 day 1)\n  * A negative serum or urine pregnancy test (investigator's discretion) within 24 hours prior to cycle 1 day 1 of study treatment\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Subjects must agree not to donate blood while receiving golcadomide, during dose interruptions and for ≥ 28 days following the last dose of golcadomide\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent that has known genotoxic, mutagenic, and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n* Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n\n  * Persons of childbearing potential (PCBP) unwilling to use two reliable forms of contraception simultaneously or to practice complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \\[e.g., calendar, ovulation, symptothermal or postovulation methods\\] and withdrawal are not acceptable methods of contraception) from heterosexual contact during the following time periods related to this study:\n  * For ≥ 28 days before starting treatment, during treatment and dose interruptions, and for ≥ 28 days after the last dose of golcadomide\n  * Examples of highly effective methods of contraception:\n\n    * Intrauterine device (IUD)\n    * Hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine system \\[IUS\\], medroxyprogesterone acetate depot injections, ovulation inhibitory\n    * Progesterone-only pills \\[e.g., desogestrel\\])\n    * Tubal ligation\n    * Partner's vasectomy\n  * Examples of additional effective methods:\n\n    * Male condom\n    * Diaphragm\n    * Cervical cap\n  * Persons who can father a child unwilling to practice complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \\[e.g., calendar, ovulation, symptothermal or post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.) or unwilling to use a condom during sexual contact with a pregnant person or a PCBP during treatment and dose interruptions, and for \\> 28 days following the last dose of golcadomide, even if they have undergone a successful vasectomy\n  * Persons who can father a child and are unwilling to refrain from donating semen or sperm while receiving golcadomide, during dose interruptions, or for ≥ 28 days following the last dose of golcadomide\n* Life expectancy \\\u003C 3 months\n* Any of the following prior therapies:\n\n  * Any prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to registration\n  * Any prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to registration, whichever is shorter\n\n    * Exception: Monoclonal and bispecific antibodies is acceptable\n  * Prior therapy with golcadomide ≤ 4 weeks prior to registration\n  * Prior autologous stem cell transplantation (SCT) ≤ 3 months prior to registration. If subject had autologous SCT \\> 3 months prior to the start of registration, any treatment-related toxicity is unresolved (grade \\> 1)\n  * Major surgery ≤ 3 weeks prior to registration\n  * Chemotherapy ≤ 2 weeks prior to registration\n  * Concomitant radiation therapy; local palliative radiotherapy is permitted\n* Co-morbid systemic illnesses or other severe concurrent disease or cancer which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Impaired cardiac function or clinically significant cardiac diseases including, but not limited to:\n\n  * Symptomatic congestive heart failure\n  * History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n* Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy (such as interstitial lung disease or chronic obstructive pulmonary disease \\[COPD\\])\n  * Any other conditions that would limit compliance with study requirements\n* Subject had prior allogeneic SCT with either standard or reduced intensity conditioning ≤ 6 months prior to registration. If subject had prior allogeneic SCT \\> 6 months prior to registration, any treatment-related toxicity is unresolved (grade \\>1)\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy, as there is currently no safety data in HIV positive patients\n* Subject has known chronic active hepatitis B or C virus (HBV\u002FHCV) infection\n\n  * Exception: Patients with HBV and an undetectable viral load who are on suppressive therapy and\u002For those with HCV and an undetectable viral load are allowed\n* Concurrent administration of strong or moderate CYP3A4\u002F5 inhibitors and inducers within 14 days or 5 half-lives, whichever is longer before the study treatment administration\n* Receiving any other investigational agent which would be considered as a treatment for lymphoma.\n\n  * Exception: Corticosteroids are allowed\n* Active second malignancy requiring treatment that would interfere with the assessment of the response of the primary cancer or interpretation of the safety of this protocol therapy\n* History of deep venous thrombosis\u002Fembolism, threatening thromboembolism or known thrombophilia. Patients with a history of deep vein thrombosis (DVT)\u002Fpulmonary embolism (PE) or thrombophilia may still participate if they are willing to be on full anticoagulation during treatment. Full anticoagulation is defined as Warfarin, factor X inhibitors, or low molecular weight heparin at therapeutic doses. The rationale for this requirement is that golcadomide therapy is associated with an increased risk of thrombosis. Patients with no history of DVT\u002FPE or thrombophilia are not required to take anticoagulation and\u002For anti-platelet prophylaxis\n\n  * NOTE: If a patient develops a thrombotic event, they must be able and willing to receive anticoagulation therapy with aspirin 81-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or Warfarin. This is due to an increased risk of thrombosis in patients treated with golcadomide without prophylaxis\n* Live COVID-19 vaccine administered ≤ 28 days prior to registration",{"count":136,"type":20},41,[24],"This phase II trial tests the effectiveness of golcadomide and rituximab as bridging treatment before chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Patients that are able to receive CAR T-cell therapy have a potential for cure, however, many will not be qualified to receive therapy due to relapse. Bridging therapy is therapy intended to transition a patient from one therapy or medication to another or maintain their health or status until they are a candidate for a therapy or have decided on a therapy. Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving golcadomide and rituximab as bridging therapy before CAR T-cell therapy may kill more tumor cells and may improve the chance of proceeding to CAR T-cell therapy in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.",[140,141,142,143,144,145,91,146,28,147,31,148,149,32,150,33,151,152,153,154,155,94,156,35,157,38,158,159,39,160,40],"Large B-Cell Lymphoma With IRF4 Rearrangement","Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma","Recurrent ALK-Positive Large B-Cell Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type","Recurrent Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation","Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Recurrent EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","Recurrent Intravascular Large B-Cell Lymphoma","Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type","Recurrent T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Refractory Aggressive B-Cell Non-Hodgkin Lymphoma","Refractory ALK-Positive Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type","Refractory Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation","Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Refractory EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","Refractory Intravascular Large B-Cell Lymphoma","Refractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type","Refractory T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","2026-01-26",{"date":163,"type":45},"2026-01-28",{"date":47,"type":45},{"date":166,"type":20},"2027-03-03",{"name":168,"class":52},"Mayo Clinic",7,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":105},"100600505","phase-1-st-067-in-combination-with-cd19-directed-car-t-cell-therapy-liso-cel-in-relapsedrefractory-large-b-cell-lymphoma-100600505","NCT07098364","ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed\u002FRefractory Large B-Cell Lymphoma","A Phase 1\u002F2 Open-Label Study Evaluating the Safety and Efficacy of ST-067 in Combination With CD19-Directed CAR T-Cell Therapy in Patients With Relapsed\u002FRefractory (R\u002FR) Large B-Cell Lymphoma (LBCL)","Inclusion Criteria:\n\n* Male or female \\>= 18 years of age at the time of consent\n* Patients with LBCL (including diffuse large B-cell lymphoma \\[DLBCL\\] not otherwise specified \\[including DLBCL arising from indolent lymphoma\\], high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B) with at least 2 lines of systemic therapy and an Food and Drug Administration (FDA)-approved indication for treatment with liso-cel\n* Fluorodeoxyglucose (FDG)-avid disease on PET imaging before lymphodepletion or pathology evidence of active disease\n* Evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology\n* Karnofsky performance status \\>= 60%\n* Adequate bone marrow function for lymphodepletion chemotherapy defined as: absolute neutrophil count (ANC) \\>= 1000 cells\u002Fmm\\^3, platelets \\>= 50,000 cells\u002Fmm\\^3, and hemoglobin \\>= 8 g\u002FdL, unless the cytopenias are due to bone marrow involvement by lymphoma in the opinion of the principal investigator (PI)\n* Calculated creatinine clearance (Cockcroft\u002FGault) \\> 30 mL\u002Fmin\u002F1.73 m\\^2\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x upper limit of normal (ULN) (or \\\u003C 5 x ULN for subjects with lymphomatous infiltration of the liver) and total bilirubin =\\\u003C 2 (or \\\u003C 3.0 for subjects with Gilbert's syndrome, lymphomatous infiltration of the liver, or hemolysis)\n* Adequate pulmonary function based on pulmonary function testing (PFT), defined as forced expiratory volume in 1 second (FEV1) and FEV1\u002Fforced vital capacity (FVC) ratio of \\>= 60% of predicted value and diffusing capacity of the lung for carbon monoxide (DLCO; corrected) \\>= 40% of predicted value\n* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA)\n* Women of reproductive potential (defined as all women physiologically capable of becoming pregnant) must agree to use suitable methods of contraception for at least 30 days after the last dose of study therapy (ST-067)\n* Males who have partners of reproductive potential must agree to use an effective barrier contraceptive method for at least 90 days after the last dose of study therapy (ST-067)\n* Ability to understand and provide informed consent\n* Able and willing to comply with study visit schedule and procedures, including tumor biopsy where feasible and with acceptable risk\n\nExclusion Criteria:\n\n* Planned use of out-of-specification liso-cel product\n* History of another malignancy. The following are exceptions to this criterion:\n\n  * Adequately treated basal cell or squamous cell carcinoma of the skin.\n  * In situ prostate, ductal breast carcinoma breast, and cervical carcinoma.\n  * Adequately treated papillary, noninvasive bladder cancer.\n  * Other adequately treated stage 1 or 2 cancers currently in complete remission.\n  * Any other cancer that has been in remission for \\>= 2 years\n* Planned use of therapeutic doses of corticosteroids (\\> 20 mg\u002Fday prednisone or equivalent) or other systemic immunosuppression within 7 days prior to leukapheresis or within 72 hours prior to liso-cel infusion. Topical and\u002For inhaled steroids are permitted\n* Prior treatment with any CD19 CAR T-cell therapy\n* For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and\u002For systemic GVHD therapy within 30 days prior to planned leukapheresis\n* Known active hepatitis B (detectable hepatitis B deoxyribonucleic acid \\[DNA\\]) or hepatitis C (detectable hepatitis C ribonucleic acid \\[RNA\\])\n* Known human immunodeficiency virus (HIV) infection\n* Pregnant or breastfeeding women\n* Prior treatment with any IL-1 or IL-18 agonist and\u002For biosimilar agents, or an investigational agent within 4 weeks or 5 half-lives, whichever is shorter, prior to start of lymphodepletion\n* Active autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., ulcerative colitis, Crohn's disease\\], celiac disease, or other serious chronic gastrointestinal conditions associated with diarrhea, autoimmune vasculitis, systemic lupus erythematosus, Wegener syndrome \\[granulomatosis with polyangiitis\\], myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) requiring immunosuppressive therapy. The following are exceptions to this criterion:\n\n  * Vitiligo.\n  * Alopecia.\n  * Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n  * Type 1 diabetes mellitus.\n  * Psoriasis not requiring systemic treatment.\n  * Conditions considered to be low risk of serious deterioration by the PI\n* History of any one of the following cardiovascular conditions within the past 6 months, unless clearance by a cardiologist is obtained: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, or unstable angina. History of other clinically significant cardiac disease that, in the opinion of the PI or designee, is a contraindication to study treatment is also excluded\n* Significant electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular (AV) block type II, third-degree AV block, \\>= grade 2 bradycardia, or QT interval corrected using Fridericia's formula \\> 500 ms irrespective of gender\n* History or presence of clinically relevant central nervous system (CNS) pathology, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis that in the opinion of the PI is a contraindication to study treatment.\n\n  * Patients with active parenchymal CNS involvement by malignancy will be excluded. Patients with prior or current secondary leptomeningeal CNS disease are eligible. CNS disease prophylaxis must be stopped at least 1 week prior to liso-cel infusion\n* History of solid organ transplantation\n* Active, serious, and uncontrolled infection(s)",{"count":178,"type":20},33,[23,24],"This phase I\u002FII trial tests the safety, side effects, and best dose\u002Fregimen of ST-067 in combination with CD19-directed chimeric antigen receptor (CAR) T-cell therapy (liso-cel) and how well it works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (recurrent) or LBCL that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Lisocabtagene maraleucel (liso-cel) is an autologous CAR T-cell therapy prepared using the person's own immune system (a group of cells, tissues, and organs that protect the body from attack by bacteria, viruses, and cancer cells) to fight the cancer. Giving ST-067 in combination with liso-cel may better treat patients with relapsed\u002Frefractory LBCL.",[27,91,28,182,183,32,34,94,35,184,185,39],"Recurrent High-Grade B-Cell Lymphoma","Recurrent Indolent B-Cell Non-Hodgkin Lymphoma","Refractory High-Grade B-Cell Lymphoma","Refractory Indolent B-Cell Non-Hodgkin Lymphoma","2026-01-13",{"date":188,"type":45},"2026-01-14",{"date":190,"type":45},"2025-12-27",{"date":192,"type":20},"2043-10-04",{"name":194,"class":52},"Fred Hutchinson Cancer Center"]