[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-transformed-indolent-b-cell-non-hodgkin-lymphoma-to-diffuse-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-transformed-indolent-b-cell-non-hodgkin-lymphoma-to-diffuse-large-b-cell-lymphoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,76],{"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":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100490909","phase-2-loncastuximab-tesirine-and-mosunetuzumab-for-the-treatment-of-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-100490909",false,"NCT05672251","Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma","A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","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* Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or 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) =\\\u003C 2.\n* Histologically confirmed diagnosis of diffuse large B-cell lymphoma or Follicular Lymphoma Grade 3B according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution. Subtypes of DLBCL including transformed indolent lymphomas (TIL) including Richter's Transformation, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma not otherwise specified (HGBCL-NOS) are eligible.\n* Life expectancy \\> 12 months.\n* Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma Grade 3B according to the WHO classification, with hematopathology review at the participating institution. Subtypes of DLBCL including transformed indolent lymphomas (TIL) including Richter's Transformation, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma not otherwise specified (HGBCL-NOS) are eligible.\n* Relapsed or refractory disease after \\>= 1 prior line of therapy (prior CD19-directed therapy and prior autologous stem cell transplant are allowed).\n\n  * Relapse at the time of study enrollment must have been confirmed histologically (with hematopathology review at the participating institution). Exceptions may be granted with study PI approval.\n* Measurable disease by computerized tomography (CT) or positron emission tomography (PET)\u002FCT scan with one or more sites of disease \\>= 1.5 cm in longest dimension.\n* Tumor must be positive for both CD19 and CD20 by immunohistochemistry after the most recent therapy.\n* Fully recovered from the acute toxic effects (except alopecia) to =\\\u003C Grade 1 to prior anti-cancer therapy\n* Without bone marrow involvement: Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3.\n\n  * (G-CSF is allowed to reach ANC requirement).\n* With bone marrow involvement: no minimum ANC requirement.\n\n  * (G-CSF is allowed to reach ANC requirement).\n* Platelets \\>= 75,000\u002Fmm\\^3.\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN).\n\n  * If hepatic involvement by lymphoma, or Gilbert's disease: =\\\u003C 3X ULN.\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN.\n\n  * If hepatic involvement by lymphoma: AST =\\\u003C 5 x ULN.\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN.\n\n  * If hepatic involvement by lymphoma: ALT =\\\u003C 5 x ULN .\n* Creatinine clearance of \\>= 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* If not receiving anticoagulants: International Normalized Ratio (INR) OR Prothrombin (PT) =\\\u003C 1.5 x ULN.\n* 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) =\\\u003C 1.5 x ULN\n* If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females of childbearing potential to abstain from heterosexual intercourse or use two adequate method of birth control, including at least 1 method with a failure rate of \\\u003C 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), until 3 months after the final dose mosunetuzumab and 9 months after the last dose of loncastuximab tesirine. Women must refrain from donating eggs during this same period. Agreement by males to abstain from heterosexual intercourse or use a condom with female partners of childbearing potential or pregnant female partners during the treatment period and for 3 months after the final dose of mosunetuzumab and 6 months after the last dose of loncastuximab tesirine. Men must refrain from donating sperm during this same period.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only) with no identified cause other than menopause.\n  * Examples of non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established and proper use of progestogen only hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices. Barrier methods must always be supplemented with the use of a spermicide. Note: Combined oral contraceptives are not recommended.\n\nExclusion Criteria:\n\n* Prior treatment with loncastuximab tesirine.\n* Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies.\n* Prior allogeneic stem cell transplantation.\n* Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 2 weeks prior to Day 1 of protocol therapy.\n* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to Day 1 of protocol therapy.\n* Treatment with radiotherapy within 2 weeks prior to Day 1 of protocol therapy.\n\n  * If patients have received radiotherapy within 4 weeks prior to prior to Day 1 of protocol therapy, patients must have at least one measurable lesion outside of the radiation field. Patients who have only one measurable lesion that was previously irradiated but subsequently progressed are eligible.\n* Autologous stem cell transplantation (SCT) within 30 days prior to prior to Day 1 of protocol therapy.\n* Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to Day 1 of protocol therapy.\n* Live vaccine within 30 days prior to Day 1 of protocol therapy.\n* Concomitant investigational therapy.\n* Treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents(e.g., immune checkpoint inhibitor therapies). Note: For certain prior treatments, such as CAR-T cell therapies, patients with prior immune-related Grade \\>= 3 adverse events (e.g., CRS) may be allowed after discussion with and approval by the Study PI.\n* Systemic steroid therapy or any other form of immunosuppressive therapy for lymphoma symptom control must be tapered down to =\\\u003C 20 mg\u002Fday prednisone or equivalent. Exceptions are:\n\n  * Inhaled or topical steroids\n  * Use of mineralocorticoids for management of orthostatic hypotension\n  * Use of physiologic doses of corticosteroids for management of adrenal insufficiency\n* Known hypersensitivity to biopharmaceutical produced in chinese hamster ovary (CHO) cells or history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents.\n* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).\n* History of solid organ transplantation.\n* History of progressive multifocal leukoencephalopathy (PML).\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Clinically significant uncontrolled illness.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with past HBV infection (defined as negative hepatitis B surface antigen \\[HBsAg\\] and positive hepatitis B core antibody \\[HBcAb\\]) are eligible if HBV deoxyribonucleic acid (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 HAART medication are allowed. Testing to be done only in patients suspected of having infections or exposures.\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection.\n* Known active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement.\n* History of erythrema multiforme, Grade \\>= 3 rash, or blistering following prior treatment with immunomodulatory derivatives.\n* Symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), cerebrovascular event\u002Fstroke or myocardial infarction within the past 6 months.\n* Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis.\n* Active autoimmune disease requiring treatment.\n* History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible.\n* Recent major surgery (within 4 weeks) prior to start of protocol therapy, other than for diagnosis.\n* History of another primary malignancy that has not been in remission for at least 2 years, with the following exceptions:\n\n  * Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease\n  * Adequately treated in situ carcinomas (e.g. cervical, esophageal) without evidence of disease\n  * Asymptomatic prostate cancer managed with a watch-and-wait strategy\n  * If the malignancy is expected to not require any treatment for at least 2 years (this exception should be discussed with the study PI).\n* Females only: Pregnant or breastfeeding.\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).","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies the safety and how well of loncastuximab tesirine when given together with mosunetuzumab works in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, loncastuximab, linked to a toxic agent called tesirine. Loncastuximab attaches to anti-CD19 cancer cells in a targeted way and delivers tesirine to kill them. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving loncastuximab tesirine with mosunetuzumab may help treat patients with relapsed or refractory diffuse large B-cell lymphoma.",[26,27,28,29,30,31,32,33,34,35,36,37],"Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Grade 3b Follicular Lymphoma","Recurrent High Grade B-Cell Lymphoma","Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Recurrent Transformed Chronic Lymphocytic Leukemia","Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Grade 3b Follicular Lymphoma","Refractory High Grade B-Cell Lymphoma","Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Refractory Transformed Chronic Lymphocytic Leukemia","Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","RECRUITING","2026-05-07",{"date":41,"type":42},"2026-05-11","ACTUAL",{"date":44,"type":42},"2024-01-02",{"date":46,"type":20},"2027-03-23",{"name":48,"class":49},"City of Hope Medical Center","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":50},"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":59,"type":20},27,[23],"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.",[26,63,27,28,64,31,32,65,33,34,66,37],"Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Recurrent Primary Mediastinal Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Refractory Primary Mediastinal Large B-Cell Lymphoma","2026-05-04",{"date":69,"type":42},"2026-05-06",{"date":71,"type":42},"2025-09-04",{"date":73,"type":20},"2033-04-11",{"name":75,"class":49},"University of Washington",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":5},"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":84,"type":20},43,[23],"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.",[63,88,64,31,65,89,66,37],"Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified","Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified","2026-04-21",{"date":92,"type":42},"2026-04-24",{"date":94,"type":42},"2026-04-15",{"date":96,"type":20},"2029-10-15",{"name":48,"class":49}]