[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-nodal-marginal-zone-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-nodal-marginal-zone-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,80,92],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100054308","phase-2-testing-mosunetuzumab-alone-with-zanubrutinib-or-with-polatuzumab-vedotin-for-treating-marginal-zone-lymphoma-that-came-back-or-didnt-get-better-with-treatment-100054308",false,"NCT07638722","Testing Mosunetuzumab Alone, With Zanubrutinib, or With Polatuzumab Vedotin for Treating Marginal Zone Lymphoma That Came Back or Didn't Get Better With Treatment","MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed\u002FRefractory Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Participants must have histologically diagnosed CD20+ marginal zone lymphoma (MZL) as per World Health Organization (WHO) criteria including splenic, nodal, and extranodal subtypes, but excluding gastrointestinal-only marginal zone lymphoma (MZL) with disease assessments that can only be evaluated through endoscopic methods and cutaneous-only MZL.\n\n  * NOTE: A repeat biopsy to confirm MZL diagnosis is NOT required at time of relapse unless:\n\n    * The participant has received prior CD3\u002FCD20 bispecific antibody, then a repeat biopsy to document continued CD20+ MZL disease is required after the completion of the prior CD3\u002FCD20 bispecific antibody therapy and prior to study registration.\n    * The participant has splenic MZL in which a bone marrow biopsy pre-registration is required within 42 days prior to registration\n* Participants must have measurable disease by PET-CT (preferred), or CT as defined by extranodal lesion ≥ 1cm or nodal lesion ≥ 1.5cm.\n\n  * Participants with splenic MZL are included in the study if spleen standardized uptake value (SUV) (or any splenic masses) is \\> liver (standardized uptake value) SUV background and\u002For spleen size is \\> 13cm.\n  * Participants must have staging imaging performed within 42 days prior to registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT scan cannot be obtained, CT scans of the neck, chest, abdomen, and pelvis, are acceptable. All disease must be assessed and documented on the Baseline Tumor Assessment Form\n* Participants must have one or more of the following criteria for further systemic therapy as per the discretion of the treating physician:\n\n  * Symptoms due to progressive or bulky nodal disease.\n  * Progressive disease that is currently compromising or may compromise normal organ function if left untreated.\n  * Presence of systemic B symptoms (i.e. fevers, weight loss, night sweats).\n  * Presence of symptomatic extranodal disease.\n  * Cytopenias due to bone marrow infiltration or hypersplenism.\n  * An increase in the tempo of disease progression\n* Participants must not have known or clinically suspected transformation to diffuse large B-cell lymphoma or high-grade B-cell lymphoma. Participants with prior transformed disease but now in relapse with MZL only are allowed on study\n* Participants with central nervous system (CNS) involvement are eligible if follow-up CNS evaluation shows no evidence of progression, or if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first eight cycles (6 months) of protocol therapy\n* Participants must have relapsed\u002Frefractory MZL after at least one line of prior CD20-directed systemic therapy (either as monotherapy or in combination with chemotherapy or lenalidomide).\n\n  * Prior antibiotic and radiation treatments for localized MZL disease are allowed and do not count as one line of systemic therapy\n* Participants who have been treated with prior Bruton's tyrosine kinase inhibitor (BTKi) or CD3\u002FCD20 targeting bispecific antibodies for their MZL must have completed treatment 180 days prior to registration and must have received a best response of either a partial or complete response\n* Participants being treated with strong and moderate CYP3A4 inducers must be off these therapies within 14 days or 5 half-lives of the drug prior to registration, whichever is shorter\n* Participants must have recovered (\\\u003C grade 2) from any side effects of prior therapy, except for alopecia and lymphopenia\n* Participants must not have been treated with prior polatuzumab vedotin for any condition\n* Participants must not have received chimeric antigen receptor T-cells (CAR-T) within 28 days prior to registration\n* Participants must not have received autologous stem cell transplantation within 100 days prior to registration\n* Participants must not have received allogeneic stem cell transplantation within 180 days prior to registration nor have active graft versus host disease requiring the current use of systemic steroid treatment ≥ 10mg of prednisone (or equivalent)\n* Participants must not have a condition requiring systemic treatment with either corticosteroids (defined as equivalent to ≥ 10mg prednisone) or other immunosuppressive medications within 7 days prior to registration.\n\n  * NOTE: Replacement steroid therapy for adrenal or pituitary insufficiency or short-term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is permitted\n* Participants must not have known clinically active post-transplant lymphoproliferative disorder\n* Participants must not have a known history of severe allergic reaction attributed to compounds of similar chemical or biologic composition to mosunetuzumab SQ, zanubrutinib or polatuzumab vedotin\n* Participants must not have received either primary or booster vaccination with live or attenuated vaccines within 28 days prior to registration\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have Zubrod Performance Status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Absolute neutrophil count ≥ 1.0 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * Note: Participants with documented MZL bone marrow involvement or a known\u002Fdocumented Fy (A-\u002FB-) immunophenotype by completed duffy antigen phenotyping (i.e. \"Duffy-Null\") must have absolute neutrophil count (ANC) ≥ 0.5 x 10\\^3\u002FuL. Growth factor use is allowed\n* Platelets ≥ 75 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * Note: Participants with documented MZL bone marrow or splenic involvement must have platelets ≥ 50 x 10\\^3\u002FuL\n* Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration)\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench\n* Participants must have an international normalized ratio (INR) \\\u003C 2 x ULN within 28 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 28 days prior to registration. To be eligible for this trial, participants must be class 2B or better, in the opinion of the treating physician\n* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 180 days prior to registration\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 180 days prior to registration, if indicated. Participants with a positive hepatitis (Hep) B core antibody are at high risk for reactivation and should receive prophylactic antiviral therapy (e.g., entecavir) before initiation of and throughout the duration of protocol treatment\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 180 days prior to registration, if indicated\n* Participants must not have any known uncontrolled intercurrent illness (in the opinion of the treating physician) that would jeopardize the participant's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, peripheral neuropathy, hypertension and gastrointestinal disorders affecting swallowing and\u002For absorption of pills\n* Participants must not require or be receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days prior to registration\n* Participants must not have a history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* Participants must not have a history of stroke or intracranial hemorrhage within 180 days prior to registration\n* Participants must not have a history of progressive multifocal leukoencephalopathy\n* Participants must not have uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura)\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete the PRO-CTCAE questionnaires in English or Spanish must be offered the opportunity to participate in the patient-reported outcome study\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","ALL","18 Years",{"count":19,"type":20},138,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial compares the effect of mosunetuzumab alone to mosunetuzumab with zanubrutinib or polatuzumab vedotin in patients with marginal zone lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as marginal zone lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79B receptors, and delivers monomethyl auristatin E to kill them. Giving mosunetuzumab alone or with zanubrutinib or polatuzumab vedotin may work well for treating relapsed or refractory marginal zone lymphoma.",[26,27,28,29,30,31],"Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Recurrent Nodal Marginal Zone Lymphoma","Recurrent Splenic Marginal Zone Lymphoma","Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Refractory Nodal Marginal Zone Lymphoma","Refractory Splenic Marginal Zone Lymphoma","NOT_YET_RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":20},"2026-10-03",{"date":40,"type":20},"2035-04-03",{"name":42,"class":43},"SWOG Cancer Research Network","NETWORK",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100585680","phase-2-epcoritamab-plus-standard-of-care-platinum-based-chemotherapy-and-autologous-hematopoietic-cell-transplant-for-the-treatment-of-relapsed-or-refractory-large-b-cell-lymphoma-100585680","NCT06905509","Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma","A Phase 2 Study of Epcoritamab (Epco) Plus Physician's Choice of Platinum-Containing Chemotherapy Pre-Autologous Hematopoietic Cell Transplantation (AutoHCT) Followed by Post-AutoHCT Epco Consolidation\u002F Maintenance in Relapsed\u002F Refractory Large B-Cell Lymphoma (R\u002FR LBCL)","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed R\u002FR LBCL\n\n  * Can include diffuse large B-cell lymphoma (DLBCL) (not otherwise specified \\[NOS\\] or with concurrent MYC and BCL2 rearrangements), high-grade B-cell lymphoma (HGBCL) (NOS or with MYC and BCL2 or BCL6 rearrangements) and transformed follicular lymphoma (FL) and nodal marginal zone lymphoma (MZL)\n  * Histological confirmed CD20+ relapsed\u002F refractory large cell lymphoma\n* Must have had relapsed or refractory disease following standard frontline chemotherapy. Refractory disease is defined as large cell lymphoma not achieving complete remission, progressing, or relapsing within 6 months after first-line chemotherapy based on PET\u002FCT per the Lugano criteria. Relapsed disease is defined as disease that recurs beyond 6 months after completion of initial chemotherapy based on PET\u002FCT per the Lugano criteria\n* Have received 1 or more prior lines of systemic therapy for the treatment of large cell lymphoma. NOTE: Prior radiation therapy or systemic corticosteroids will not be considered a line of therapy\n* Candidate for platinum-containing chemotherapy (RICE, RDHAP\u002FX, or R-Gem\u002FOx) pre-autologous hematopoietic cell transplantation (autoHCT) followed by autoHCT as per institutional guidelines\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Measurable disease via diagnostic quality CT or PET\u002FCT with at least 1 node having the longest diameter (LDi) greater than (\\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \\> 1 cm (per the Lugano criteria 2014)\n* Aged ≥ 18 at the time of consent\n* Creatinine clearance (CrCl) ≥ 45 mL\u002Fmin (Cockcroft-Gault)\n* Serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)\n* Serum aspartate aminotransferase (AST) ≤ 3 x ULN\n* Bilirubin ≤ 1.5 x ULN unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia (not requiring immunosuppressive other than ≤ 20 mg of prednisolone daily)\n\n  * Note: Patients with Gilbert's syndrome may be included if total bilirubin is ≤ 3 x ULN and direct bilirubin is ≤ 1.5 x ULN\n* Hemoglobin ≥ 8.0 g\u002FdL\n\n  * Note: Blood transfusion may be administered during Screening to meet this requirement only if anemia is due to marrow involvement of non-Hodgkin lymphoma (NHL)\n* Absolute neutrophil count ≥ 1000\u002FuL\n\n  * Note: Growth factor support is allowed to meet this requirement at Screening only if directly attributable to NHL infiltration of the bone marrow, proven by bone marrow biopsy\n* Platelet count ≥ 75,000\u002FuL or ≥ 50,000\u002FuL if bone marrow (BM) involvement or splenomegaly\n\n  * Note: Transfusion may be administered during screening to meet this requirement\n* prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n* Note: If any of the above-mentioned cytopenias are present, there should be no evidence of myelodysplastic syndrome (MDS) or hypoplastic bone marrow\n* HIV-infected patients on effective anti-retroviral therapy with stable viral load and CD4 count for 1 year prior to enrollment are eligible for this trial. Testing for HIV viral load and antibody at screening is mandatory\n* Patients with a history of chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load on suppressive therapy, if indicated. Patients with evidence of prior HBV but who are polymerase chain reaction (PCR)-negative are permitted in the trial but should receive prophylactic antiviral therapy. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Patients who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C ribonucleic acid (RNA) levels are undetectable. Testing for HBV and HCV is mandatory at screening\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 12 months after the last dose of epcoritamab\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n* Any adverse event (AE) related to the previous large cell lymphoma therapy which has not recovered to grade ≤ 1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v.\\] 5.0) or baseline by cycle 1 day 1 (C1D1), except alopecia and non-clinically significant laboratory abnormalities\n* Uncontrolled intercurrent illness (including infection)\n* Known active central nervous system or meningeal (including leptomeningeal) involvement. Patients diagnosed with central nervous system (CNS) disease who achieved and maintained CNS complete response (CR) at the time of relapse are eligible. Lumbar puncture must be done in this case prior to study entry (within 90 days of enrollment) to demonstrate CNS CR status. Tests to investigate CNS involvement are required otherwise only if clinically indicated (i.e. disease suspected on basis of symptoms or other findings)\n* Receiving any other investigational treatments\n* Previous treatment with any bispecific T-cell engager with or without chemotherapy\n* Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab\n* Concurrent use of other anti-cancer agents or treatments except for certain therapeutics (e.g., prostate, breast hormonal-based therapy) per the treating physician's discretion\n\n  * Standard agents within 2 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab (excluding anti-CD20 monoclonal antibodies \\[mAbs\\], which can be administered until first full dose of epcoritamab); or\n  * CAR-T cell therapy within 30 days prior to the first dose of epcoritamab\n  * Palliative radiation is permitted only if on non-target lesions\n* Motor and sensory neuropathy grade ≥ 2 (CTCAE v.5.0)\n* Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, non-invasive superficial bladder cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, localized low grade prostate cancer (up to Gleason score 6), or other solid tumors curatively treated with no evidence of disease for at least 3 years\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrollment or significant infections within 2 weeks prior to the first dose of epcoritamab\n* Confirmed history or current autoimmune disease or other diseases requiring permanent immunosuppressive therapy. Low-dose (10 mg\u002Fday) prednisolone (or equivalent) for rheumatoid arthritis or similar conditions is allowed\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)\n* Participant received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation\n* Autoimmune disease or other diseases that require continuous immunosuppressive therapy (except for prednisone doses of less than or equal to 10 mg, which is allowed)\n* Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia (requiring \\> 20 mg of prednisolone daily) or other concurrent uncontrolled medical conditions\n* Clinically significant cardiac disease including but not limited to:\n\n  * Unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function, e.g., unstable angina, congestive heart failure grade III or IV as classified by the New York Heart Association, uncontrolled clinically significant cardiac arrhythmia (CTCAE v 5.0 grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities. Controlled New York Heart Association (NYHA) grade 1 or 2 are eligible\n  * Myocardial infarction, intracranial bleed, or stroke within the past 6 months\n  * Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \\> 480 msec. NOTE: This criterion does not apply to participants with a left bundle branch block\n  * In case of any history of cardiovascular disease, a cardiology consult is required within 60 days prior to enrollment\n  * Age ≥ 75 and 2 or more active grade ≥ 2 cardiovascular conditions\n* Prior treatment with live, attenuated vaccines within 28 days prior to initiation of epcoritamab. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, bacillus Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Food and Drug Administration (FDA)-approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations allowed\n* Immune effector cell encephalopathy (ICE) score of less than 10 at study entry\n* Suspected allergies, hypersensitivity, or intolerance to epcoritamab or another anti-CD20 mAb or its excipients\n* Active HBV (DNA PCR-positive). Patients with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy\n* Active hepatitis C (RNA PCR-positive infection). Patients who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable\n* Known history of seropositivity for HIV infection\n* Active cytomegalovirus (CMV) infection (PCR positive)\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab\n* Plans to donate sperm or conceive a child through intercourse while enrolled in this trial or within 12 months after the last dose of epcoritamab\n* Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to the first dose of epcoritamab\n* Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection. Note: SARS-CoV-2 diagnostic tests should be applied following local requirements\u002Frecommendations. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen per criteria\n* Suspected active or inadequately treated latent tuberculosis",{"count":52,"type":20},25,[23],"This phase II trial tests how well epcoritamab in combination with standard of care (SOC) platinum-based chemotherapy (rituximab, ifosfamide, carboplatin, etoposide \\[RICE\\], rituximab, cytarabine, dexamethasone, oxaliplatin or carboplatin RDHAP\u002FX\\] or gemcitabine and oxaliplatin \\[Gem\u002FOx\\]) and autologous hematopoietic cell transplant (HCT) works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab, a type of bispecific T-cell engager, 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. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs, such as ifosfamide, etoposide phosphate, cytarabine, and gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. An autologous HCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving epcoritamab in combination with SOC platinum-based chemotherapy, such as RICE, RDHAP\u002FX and Gem\u002FOx, and autologous HCT may kill more cancer cells in patients with relapsed or refractory LBCL.",[56,57,58,59,60,27,61,62,63,64,65,66,30,67],"Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","Recurrent High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements","Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","Refractory High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements","Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified","Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma","RECRUITING","2026-06-25",{"date":71,"type":36},"2026-06-30",{"date":73,"type":36},"2025-07-31",{"date":75,"type":20},"2030-08-01",{"name":77,"class":78},"University of California, Davis","OTHER",1,{"id":81,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":24,"conditions":84,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100643099",{"count":19,"type":20},[23],[26,27,28,29,30,31],"2026-06-05",{"date":87,"type":36},"2026-06-10",{"date":38,"type":20},{"date":90,"type":20},"2029-07-31",{"name":42,"class":43},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":79},"100582107","phase-1-zanubrutinib-in-combination-with-sonrotoclax-for-the-treatment-of-underrepresented-ethnic-and-racial-minorities-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-100582107","NCT06859008","Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","Feasibility of Treating Relapsed\u002FRefractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic\u002FRacial Minorities","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* Age: ≥ 18 years on the day of signing the informed consent form\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Patients are of the following self-identified racial\u002Fethnic groups:\n\n  * Cohort 1: Patients in any of the following categories:\n\n    * Black or African American\n    * Hispanic or Latino\n    * American Indian\u002FNative Alaskan\n    * Pacific Islander\u002FNative Hawaiian\n    * Any other patient that does not fit the definition of Cohort 2\n  * Cohort 2: Patients in either of following categories:\n\n    * Non-Hispanic White\n    * Non-Hispanic Asian\n* Confirmed diagnosis (per World Health Organization \\[WHO\\] guidelines, unless otherwise noted) of one of the following disease subtypes. Note that for disease subtypes that are known to respond to BTK inhibitor (BTKi) and\u002For BCL2 inhibitor (BCL2i) (e.g., marginal zone lymphoma \\[MZL\\], mantle cell lymphoma \\[MCL\\], CLL\u002FSLL), newly diagnosed or r\u002Fr patients are allowed\n\n  * Diffuse large B cell lymphoma (DLBCL)\n\n    * R\u002FR DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least 2 prior lines of therapy. Patients should be considered by the investigator to be refractory to or not a candidate for approved therapies with proven efficacy including but not limited to chimeric antigen receptor (CAR) T cell therapy or bispecific antibody therapy\n    * Active disease requiring treatment\n  * Follicular lymphoma (FL)\n\n    * R\u002FR FL (grade 1, 2 or 3a based on WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy. Patients should be considered by the investigator for all approved therapies with proven efficacy including but not limited to CAR T cell therapy or bispecific antibody therapy\n    * Active disease requiring treatment\n  * Marginal zone lymphoma (MZL)\n\n    * R\u002FR extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least 1 prior therapy\n    * Active disease requiring treatment\n  * Mantle cell lymphoma (MCL)\n\n    * R\u002FR MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy\n    * Requiring treatment in the opinion of the investigator\n  * Chronic lymphocytic leukemia\u002Fsmall lymphocytic leukemia (CLL\u002FSLL)\n\n    * CLL\u002FSLL diagnosis that meets the International Workshop on CLL (International Workshop on Chronic Lymphocytic Leukemia \\[IWCLL\\]) criteria\n    * Patients with previously untreated and\u002For r\u002Fr CLL defined as disease that relapsed after, or was refractory to, at least 1 prior therapy will be included\n    * Patients must have an indication to start treatment\n* Measurable disease, defined as:\n\n  * CLL: at least 1 lymph node \\> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) or clonal lymphocytes measured by flow cytometry\n  * DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node \\> 1.5 cm in longest diameter OR 1 extranodal lesion \\> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions by CT\u002FMRI. For MZL, isolated splenomegaly is considered measurable for this study. For MCL, clonal lymphocytes measured by flow cytometry is considered measurable\n* Life expectancy of ≥ 6 months\n* Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* With bone marrow involvement: ANC ≥ 500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Without bone marrow involvement: Platelets ≥ 75,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* With bone marrow involvement: Platelets ≥ 30,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 7g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 7 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Fridericia's formula-corrected QT interval (QTcF) ≤ 480 ms\n\n  * Note: Performed within 28 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) 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  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\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 protocol therapy\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 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 90 days 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* Major surgery ≤ 4 weeks of the first dose of study drug\n* Prior autologous stem cell transplant unless ≥ 30 days after transplant; or prior chimeric antigen receptor T cell (CAR-T) therapy unless ≥ 30 days after cell infusion\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* Prior therapy ≥ 2 months with or progression on a Bcl2 inhibitor (eg, venetoclax)\n* Vaccination or requirement for vaccination with a live vaccine within 35 days prior to the first dose of study drug or at any time during planned study treatment\n* Requires ongoing treatment with a strong CYP3A inducer\n* Requires ongoing treatment with warfarin or warfarin derivatives\n* Concurrent participation in another therapeutic clinical trial\n* Use of the following substances prior to the first dose of study drug:\n\n  * ≤ 28 days before first dose of study drug: Any biologic and\u002For immunologic-based therapy(ies) including experimental therapy(ies) for leukemia, lymphoma, or myeloma (including, but not limited to, monoclonal antibody therapy, eg, rituximab, and\u002For cancer vaccine therapy)\n  * ≤ 14 days before the first dose of study drug: systemic chemotherapy or radiation therapy\n  * ≤ 7 days before the first dose of study drug: corticosteroid given with antineoplastic intent other than control of BTK inhibitor withdrawal flare\n  * ≤ 5 half-lives before the first dose of study drug: BTK inhibitor, tyrosine kinase inhibitor, or other targeted small molecule given with antineoplastic intent\n* Known current central nervous system involvement by lymphoma\u002Fleukemia\n* Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome\n* Any uncontrolled or clinically significant cardiovascular disease including the following:\n\n  * Myocardial infarction (MI) within 6 months before screening\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Unstable angina within 3 months before screening\n  * History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n  * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n* Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer\n* History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n* Severe or debilitating pulmonary disease\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* Active fungal, bacterial and\u002For viral infection requiring systemic therapy\n* Underlying medical conditions that, in the investigator's opinion, will render the administration of study drugs hazardous or obscure the interpretation of toxicity or adverse events (AEs)\n* Known active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:\n\n  * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable (\\\u003C 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation\n  * Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable\n* Any condition which in the discretion of the investigator would compromise the ability to comply with study procedures\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents\n* Active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (e.g., idiopathic thrombocytopenia purpura)\n* Females only: Pregnant or breastfeeding\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":100,"type":20},37,[102],"PHASE1","This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.",[105,106,56,26,107,108,109,110,27,28,111,62,29,112,113,114,115,30,31],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Recurrent Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Recurrent Grade 1 Follicular Lymphoma","Recurrent Grade 2 Follicular Lymphoma","Recurrent Grade 3a Follicular Lymphoma","Recurrent Mantle Cell Lymphoma","Refractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Refractory Grade 1 Follicular Lymphoma","Refractory Grade 2 Follicular Lymphoma","Refractory Grade 3a Follicular Lymphoma","Refractory Mantle Cell Lymphoma","2026-04-16",{"date":118,"type":36},"2026-04-20",{"date":120,"type":36},"2025-08-25",{"date":122,"type":20},"2029-01-31",{"name":124,"class":78},"City of Hope Medical Center"]