[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-polymorphic-post-transplant-lymphoproliferative-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-polymorphic-post-transplant-lymphoproliferative-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100571684","phase-2-epcoritamab-and-lenalidomide-in-treating-patients-with-refractory-or-relapsed-immunodeficiency-related-large-b-cell-lymphoma-100571684",false,"NCT06723457","Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma","A Phase II Study of Combination Epcoritamab-Lenalidomide in Patients With Refractory\u002FRelapsed Immunodeficiency-Related Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Patients must have a pathologically confirmed diagnosis of immunodeficiency-related large B-cell lymphoma as defined by the 5th Edition of the World Health Organization (WHO) Classification of Hematolymphoid Tumors 2022 in addition to any of the following:\n\n  * Lymphomas arising in immune deficiency which encompass monomorphic post-transplant lymphoproliferative disorder (PTLD) OR\n  * Polymorphic B-cell lymphoproliferative disorder arising in the setting of immunodeficiency and\u002For immune dysregulation as seen in 1 or more of the following settings:\n  * Underlying autoimmune disease\n  * Iatrogenic or therapy-related immunosuppression\n  * Conditions arising from inborn errors of immunity\n  * Immune senescence as seen in patients aged ≥80 years or those ≥ 65 years with CD4 count \\\u003C 500 cells\u002Fmm\\^3\n  * Epstein-Barr virus (EBV) infection as demonstrated by EBV positivity in the tumor cells\n* Patients must have measurable disease (≥ 1 measurable nodal lesion \\[long axis \\> 1.5 cm\\] or ≥ 1 measurable extra-nodal lesion \\[long axis \\> 1.0 cm\\] on CT scan or MRI) per Lugano criteria\n\n  * Note; Patients with hepatomegaly \u002Forganomegaly deemed to be related to disease will also be eligible if not meeting strict Lugano criteria\n* Patients must meet one disease status as follows AND deemed ineligible for chimeric antigen receptor T-cell (CAR-T):\n\n  * Primary refractoriness defined as a partial response or less on interim PET-CT during therapy with frontline chemo-immunotherapy (containing anti-CD20 monoclonal antibody)\n  * Primary refractoriness defined as a partial response or less on interim PET-CT during therapy with rituximab (or any other anti-CD20 monoclonal antibody) monotherapy AND deemed ineligible for escalation to chemotherapy\n  * Relapse after achieving a complete response with ≥ 1 prior systemic therapy (including CART)\n* Patients must be aged ≥ 18 years\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Absolute neutrophil count (ANC) ≥ 1000\u002FmcL (the use of growth factor support to attain goal ANC allowed, but not the last 14 days prior to screening laboratory test)\n* Platelets (PLT) ≥ 50,000\u002FmcL (transfusions allowed ≥ 7 days prior)\n* Total bilirubin ≤ 1.5 Institutional upper limit of normal (ULN) unless attributed to Gilbert's ≤ 3 Institutional ULN if attributed to disease or Gilbert's\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (\\> 3 and ≤ 5 x institutional upper limit of normal (ULN) if deemed related to disease)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin\u002F1.73 m2\n\n  * Estimated (e)GFR is calculated by the abbreviated Modification of Diet in Renal Disease (MDRD)\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* 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* The effects of lenalidomide on the developing human fetus are known. For this reason and because lenalidomide as well as other therapeutic agents used in this trial are known to be teratogenic, females of child-bearing potential (FOCBP) must agree to use adequate contraception. Female subjects of reproductive potential must either completely abstain from heterosexual sexual contact or must use 2 effective methods of contraception (at least 1 highly effective method and one effective method) at the same time\n\n  * The 2 effective contraceptive methods must be started at least 30 days before lenalidomide therapy, during therapy (including dose interruptions), and for at least 12 months following discontinuation of therapy\n  * Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n  * Females should also refrain from egg donation from the time of informed consent, during the study and for 12 months after the last dose of study drug\n  * NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n  * Has not undergone a hysterectomy or bilateral oophorectomy\n  * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n  * If male, and subject is sexually active with female partner(s) of childbearing potential, he must agree, from 30 days prior to randomization through 12 months after the last dose of study drug, to practice the protocol-specified contraception\n  * Male who is not considering fathering a child or donating sperm during the study or for 12 months after the last dose of study drug\n  * FOCBP must have a negative pregnancy test prior to registration on study\n* Patients must have no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.\n\n  * (If a patient has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the patient must have a negative molecular (e.g., polymerase chain reaction \\[PCR\\]) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection)\n  * Note: SARS-CoV-2 diagnostic tests should be applied following local requirements\u002Frecommendations.\n  * Patients who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:\n\n    * No signs\u002Fsymptoms suggestive of active SARS-CoV-2 infection\n    * Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart)\n\nExclusion Criteria:\n\n* Patients who have received any prior therapy with a bispecific T-cell engager targeting CD3 and CD20\n* Patients who have received chemotherapy and\u002For other antineoplastic agents (except CD20- targeting monoclonal antibodies, steroids and\u002For radiation) within 1 week or 5 half-lives (whichever is shorter) prior to registration\n* Patients who have undergone autologous stem cell transplant (ASCT) within 100 days of registration\n* Patients who have undergone CAR-T therapy with refractoriness or relapse within 30 days of registration\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab and\u002For lenalidomide\n* Patients with human immunodeficiency virus (HIV) with detectable viral load and CD4 count ≤350 cells\u002Fmm3 \\& not on treatment for more than 1 year\n* Patients with evidence of active disease in the central nervous system (CNS) defined as either the presence of active lesions on MRI or cerebrospinal fluid (CSF) studies obtained within 4 weeks prior to registration or progressive neurological decline, attributable to CNS disease\n* Patients who have a seizure disorder that is not controlled (requiring anti-epileptic therapy AND with seizure within 12 months of registration)\n* Patients who have had major surgery within 4 weeks prior to registration\n* Patients who have clinically significant cardiac disease include the following:\n\n  * Myocardial infarction or stroke within 6 months prior to enrollment,\n  * OR the following conditions within 6 months prior to enrollment: unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV), uncontrolled cardiac arrhythmia, and uncontrolled hypertension),\n  * OR Other clinically significant electrocardiogram (ECG) abnormalities within 6 months prior to enrollment unless deemed stable and appropriately treated\n  * OR Left ventricular ejection fraction \\\u003C 45% for Echocardiogram\n* Patients who are unable to swallow, retain and absorb oral tablet\u002Fgel\u002Fcapsules\n* Patients who have received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention.\n\n  * Note: Administration of killed vaccines is allowed\n* Female patients who are pregnant or nursing.\n\n  * Note: Females should refrain from breast feeding from the time of informed consent, during the study and for 12 months after the last dose of study treatment\n* Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:\n\n  * Ongoing or active infection requiring IV antimicrobial treatment\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints","ALL","18 Years",{"count":19,"type":20},34,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well the combination of epcoritamab and lenalidomide work in treating patients with immunodeficiency-related large B-cell lymphoma that does not respond to treatment (refractory) or that has come back after a period of improvement (relapsed). Epcoritamab is an immunotherapy that engages T-cells in the immune system to help redirect their killing effects against lymphoma cells. Lenalidomide can modulate the immune system to enhance killing effects of lymphoma by the immune system as well. Giving patients a combination of epcoritamab and lenalidomide may work better in treating refractory or relapsed immunodeficiency-related large B-cell lymphoma.",[26,27,28],"Recurrent B-Cell Non-Hodgkin Lymphoma","Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder","Refractory B-Cell Non-Hodgkin Lymphoma","RECRUITING","2026-07-06",{"date":32,"type":33},"2026-07-08","ACTUAL",{"date":35,"type":33},"2025-07-25",{"date":37,"type":20},"2029-02-18",{"name":39,"class":40},"Reem Karmali","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100567785","phase-1-epcoritamab-for-the-treatment-of-relapsed-or-refractory-post-transplant-lymphoproliferative-disorders-100567785","NCT06672705","Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders","Phase Ib Study to Assess the Efficacy and Safety of Epcoritamab in Relapsed or Refractory Post-Transplant Lymphoproliferative Disorder","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information to the sponsor, sites, and relevant study organizations.\n* Age ≥ 18 years at the time of consent.\n* Karnofsky scale ≥ 50% or Eastern Cooperative Oncology Group (ECOG) ≤ 2.\n* Histological evidence of B-cell PTLD (any histologic subtype) following solid organ transplantation; expresses CD20; with or without EBV association.\n* Treatment failure of immunosuppression reduction (ISR). NOTE: if ISR was deemed not feasible by treating physician, ISR treatment failure may be waived.\n* Treatment failure of rituximab or rituximab plus any concurrent or sequentially administered chemotherapy regimen.\n* Measurable disease of \\> 1.5 cm in diameter and\u002For bone marrow involvement.\n* Subjects having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or a combination of the organ transplantations mentioned.\n* HIV infection is allowed if viral load is undetectable at time of enrollment, CD4+ count \\> 200 cells\u002FuL, and subject remains on anti-viral therapy.\n* Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator.\n* Expected survival greater than 60 days.\n* Absolute neutrophil count 1.0 ≥ x 10\\^9\u002FL.\n* Platelets 50 ≥ x 10\\^9\u002FL.\n* Creatinine clearance (mL\u002Fmin) ≥ 30 mL\u002Fmin - Cockcroft-Gault Equation.\n\n  * Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy.\n* Bilirubin ≤ 3.0 x upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \\> 3.0 mg\u002FdL if their conjugated bilirubin is ≤ 3.0 × ULN).\n\n  * Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy.\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN.\n\n  * Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy.\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN.\n\n  * Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy.\n* Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to registration. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided.\n* Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after treatment the last dose of epcoritamab. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device.\n* Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 12 months after the last dose of epcoritamab.\n* Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the experimental regimen are eligible for the trial.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.\n\nExclusion Criteria:\n\n* Uncontrolled active (symptomatic) infection. Patients requiring systemic therapy are eligible if the infection is deemed controlled by the investigator.\n* Post-transplant lymphoproliferative disorder following stem cell transplantation for hematologic malignancies or nonmalignant conditions.\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drug).\n* Subjects with central nervous system (CNS) involvement by PTLD.\n* Seizure disorder requiring therapy (such as steroids or anti-epileptics).\n* Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association (NYHA) Class III or IV), unstable angina pectoris, myocardial infarction within 1 month prior to enrollment, uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe non-compensated hypertension (systolic blood pressure \\> 180mmHg or diastolic blood pressure \\> 120mmHg).\n* History of progressive multifocal leukoencephalopathy.\n* Active Hepatitis B infection or Hepatitis C infection with positive viral polymerase chain reaction (PCR) from the blood. Subjects with active Hepatitis B infection and undetectable viral PCR from the blood will be allowed with concurrent use of entecavir suppression. Subjects with history of Hepatitis C infection (undetectable viral PCR) are allowed.\n* Electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant.\n* Any condition, including the presence of laboratory values which is deemed by the clinician to place the subject at an unacceptable risk or confounds the ability to interpret the data from this study.\n* Live virus vaccines must not be administered within 28 days of the start of study treatment.\n* Any investigational treatments must have been completed at least 4 weeks or 5 half-lives, whichever is shorter, prior to the start of study treatment. Investigational antibody therapies are not included in this requirement.",{"count":50,"type":20},26,[52],"PHASE1","This phase Ib trial tests the safety and effectiveness of epcoritamab in treating patients with post-transplant lymphoproliferative disorder (PTLD) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Giving epcoritamab may be safe and effective in treating patients with relapsed or refractory B-cell PTLD.",[55,56,57,27,58,59],"Diffuse Large B-Cell Lymphoma Post-Transplant Lymphoproliferative Disorder","EBV-Related Post-Transplant Lymphoproliferative Disorder","Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder","Refractory Monomorphic Post-Transplant Lymphoproliferative Disorder","Refractory Polymorphic Post-Transplant Lymphoproliferative Disorder","2025-08-14",{"date":62,"type":33},"2025-08-19",{"date":64,"type":33},"2025-06-16",{"date":66,"type":20},"2026-12-31",{"name":68,"class":40},"Timothy Voorhees"]