[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-transformed-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-transformed-non-hodgkin-lymphoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,85,113],{"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":72,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100506386","phase-2-zanubrutinib-and-lisocabtagene-maraleucel-for-the-treatment-of-richters-syndrome-100506386","NCT05873712","Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome","A Phase II Study Evaluating the Safety and Efficacy of the Combination of Zanubrutinib Plus Lisocabtagene Maraleucel for Richter's Syndrome","Inclusion Criteria:\n\n* Diagnosis of RS - occurrence of diffuse large B-cell lymphoma (DLBCL) in patients with antecedent or concurrent CLL\u002FSLL (CLL\u002FSLL diagnosis per IWCLL 2018 criteria).\n* Must have relapsed\u002Frefractory disease as defined by one of the following:\n\n  * Participants must have undergone \\>= 1 prior systemic therapeutic regimen administered for \\>= 1 cycle for either CLL or RS, and have had either documented disease progression to the most recent treatment regimen, or refractory disease. OR\n  * Developed RS while receiving treatment for CLL\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Total bilirubin =\\\u003C 2.0 times the institutional upper limit of normal (unless documented Gilbert's syndrome)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 2.5 x institutional upper limit of normal\n* Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional upper limit of normal\n* Creatinine clearance \\>= 30 mL\u002Fmin\n\n  * Using 24-hour creatinine clearance or standard Cockcroft-Gault equation\n* Absolute lymphocyte count \\> 100\u002FuL at screening\n* Left ventricular ejection fraction \\>= 40% by multigated acquisition (MUGA) or echocardiogram (ECHO)\n* Adequate bone marrow independent of growth factor support or infusion support at screening unless evidence shows that the cytopenia(s) is due to marrow involvement by CLL\u002Fsmall lymphocytic lymphoma (SLL). If cytopenias are due to disease in the bone marrow any degree of anemia or thrombocytopenia are allowed, absolute neutrophil count (ANC) must be \\>= 500\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (independent of growth factor support or infusion support at screening unless evidence shows that the cytopenia\\[s\\] is due to marrow involvement by CLL\u002FSLL). If cytopenias are due to disease in the bone marrow any degree of anemia or thrombocytopenia are allowed, ANC must be \\>= 500\n* Platelets \\>= 30,000\u002Fmm\\^3 (independent of growth factor support or infusion support at screening unless evidence shows that the cytopenia\\[s\\] is due to marrow involvement by CLL\u002FSLL). If cytopenias are due to disease in the bone marrow any degree of anemia or thrombocytopenia are allowed\n* Hemoglobin \\>= 7 g\u002FdL (independent of growth factor support or infusion support at screening unless evidence shows that the cytopenia\\[s\\] is due to marrow involvement by CLL\u002FSLL). If cytopenias are due to disease in the bone marrow any degree of anemia or thrombocytopenia are allowed\n* Radiographically measurable lymphadenopathy (or measurable extra-nodal disease) per Lugano criteria\n* Must meet all institutional standards for receiving CAR T-cell therapy\n* Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year, initiated prior to first dose of study drug, during the treatment period and for at least 1 year after the CAR-T cell infusion or 1 month after last dose of zanubrutinib, whichever is longer.\n\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). 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* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after the anti-CD19 CAR-T cell infusion or 1 month after last dose of zanubrutinib, whichever is longer. Men should avoid fathering a child and refrain from donating sperm during this same period.\n  * With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 1 year after the human anti- CD19 CAR-T cell infusion or 1 month post last dose of zanubrutinib, whichever is longer, to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n\nExclusion Criteria:\n\n* A history of treatment including any of the following: prior CD19 directed therapy, treatment with alemtuzumab within 6 months before enrollment, prior allogeneic hematopoietic stem cell transplant (SCT) or donor lymphocyte infusion (DLI) within 2 months prior to enrollment\n* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent\n* Inadequate recovery from adverse events related to prior therapy to grade =\\\u003C 1 (excluding grade 2 alopecia, neuropathy, and hypertension)\n* Is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication\n* Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)\n* Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)\n* Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening\n* Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled atrial fibrillation\u002Fflutter can enroll on study\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR) or activated partial thromboplastin time (PTT) (in the absence of lupus anticoagulant) \\> 2 x upper limit normal (ULN)\n* Treatment with a moderate or strong CYP3A inhibitor or inducer within 7 days prior to first dose of zanubrutinib\n* Patients may not have an active intercurrent disease or concurrent malignancy that is expected to limit survival to \\\u003C 5 years\n* Human immunodeficiency virus (HIV) seropositivity at screening\n* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, unstable angina pectoris, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\n* Serologic status reflecting active hepatitis B or C infection at screening. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) at screening. PCR positive patients will be excluded\n* History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months\n* Chronic use of corticosteroids \\>= 20mg prednisone equivalent PO daily\n* Live vaccines given in 28 days prior to lymphodepleting chemotherapy",{"count":62,"type":20},24,[24],"This phase II trial tests how well zanubrutinib and lisocabtagene maraleucel (liso-cel) work together in treating patients with Richter's syndrome that has come back (recurrent) or does not respond to treatment (refractory). Richter's syndrome occurs when chronic lymphocytic leukemia and\u002For small lymphocytic leukemia transforms into an aggressive lymphoma, which is a cancer of the lymph nodes. Zanubrutinib is a class of medication called a kinase inhibitor. These drugs work by preventing the action of abnormal proteins that tell cancer cells to multiply, which helps stop the spread of cancer. Liso-cel is a type of treatment known as chimeric antigen receptor (CAR) T cell therapy. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving zanubrutinib and liso-cell together may kill more cancer cells in patients with recurrent or refractory Richter's syndrome.",[66,67,68,69,33,40,70,71],"Recurrent Transformed Chronic Lymphocytic Leukemia","Refractory Transformed Chronic Lymphocytic Leukemia","Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma","Recurrent Transformed B-Cell Non-Hodgkin Lymphoma","Refractory Transformed B-cell Non-Hodgkin Lymphoma","Refractory Transformed",[73,74],"Richter's Transformation","Richter's Syndrome","2026-02-27",{"date":77,"type":45},"2026-03-03",{"date":79,"type":45},"2023-07-28",{"date":81,"type":20},"2026-12-31",{"name":83,"class":52},"Aseel Alsouqi",3,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100472496","phase-1-genetically-modified-t-cells-cmv-specific-cd19-car-t-cells-plus-a-vaccine-cmv-mva-triplex-following-stem-cell-transplantation-for-the-treatment-of-intermediate-or-high-grade-b-cell-non-hodgkin-lymphoma-100472496","NCT05432635","Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma","Pilot\u002FFeasibility Study of CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Following Autologous Hematopoietic Stem Cell Transplantation for Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma (B-NHL)","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 PI approval\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated full consent is processed\n* Age \\>= 18 years\n* Karnofsky performance status (KPS) \\>= 70\n* Life expectancy \\>= 16 weeks at the time of enrollment\n* Patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma \\[DLBCL\\], mantle cell lymphoma \\[MCL\\], or transformed NHL) in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy\n\n  * Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy\n* No known contraindications to myeloablative HSCT, leukapheresis, steroids or tocilizumab, smallpox vaccine and any other modified vaccinia Ankara (MVA)-based vaccines\n* Patient must be CMV seropositive\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL\n* Participants with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0\n* Aspartate aminotransferase (AST) \\\u003C 2.5 x upper limits of normal (ULN)\n* Alanine aminotransferase (ALT) \\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 2.5 x ULN or estimated creatinine clearance of \\>= 40 mL\u002Fmin per the Cockcroft-Gault formula, and the participant is not on hemodialysis\n* Absolute neutrophil count \\>= 1000\u002FuL (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Hemoglobin (Hb) \\>= 8 g\u002Fdl (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Platelet count \\>= 50,000\u002FuL (\\>= 30,000\u002FuL if bone marrow plasma cells are =\\> 50 percent of cellularity) (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Left ventricular ejection fraction \\>= 45 percent within 8 weeks before enrollment\n* Oxygen (O2) saturation \\> 92% without requiring supplemental oxygen\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n* 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 activity for the course of the study through at least 6 months after the last dose of protocol therapy.\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)\n\nExclusion Criteria:\n\n* Prior autologous\u002Fallogeneic stem cell transplant\n* Growth factors within 14 days of enrollment\n* Platelet transfusions within 7 days of enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\\\u003C 5 mg \u002Fday, or equivalent doses of other corticosteroids) is allowed\n* Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed\n* Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy\n* Any standard contraindications to myeloablative HSCT per standard of care practices at COH\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening\n* Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any other active CNS disease. Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\\\u003C 5 white blood cells \\[WBC\\] \u002F mm\\^3 and no blasts in cerebrospinal fluid \\[CSF\\]) will be eligible\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \\>= 3 years.\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Immunodeficiency virus (human immunodeficiency virus \\[HIV\\]) positive\n* Active viral hepatitis\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Procedures (including compliance issues related to feasibility\u002Flogistics). Prospective participants who, in the opinion of the investigator, may not be able to comply with all study\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":93,"type":20},15,[23],"This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.",[97,98,99,100,27,101,33,102],"B-Cell Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma","Mantle Cell Lymphoma","Recurrent B-Cell Non-Hodgkin Lymphoma","Recurrent Mantle Cell Lymphoma","Transformed Non-Hodgkin Lymphoma","2026-02-20",{"date":105,"type":45},"2026-02-23",{"date":107,"type":45},"2023-08-01",{"date":109,"type":20},"2028-12-30",{"name":111,"class":52},"City of Hope Medical Center",1,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"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":121,"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.",[125,126,127,128,129,130,131,132,28,133,31,134,135,32,136,33,137,138,139,140,141,142,143,35,144,38,145,146,39,147,40],"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 Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","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 Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","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":150,"type":45},"2026-01-28",{"date":47,"type":45},{"date":153,"type":20},"2027-03-03",{"name":155,"class":52},"Mayo Clinic",7]