[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extranodal-marginal-zone-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extranodal-marginal-zone-lymphoma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":33,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100637441","phase-2-non-covalent-btk-inhibitor-nemtabrutinib-in-combination-with-the-cd20-monoclonal-antibody-rituximab-for-the-treatment-of-marginal-zone-lymphoma-100637441",false,"NCT07583810","Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma","A Phase II Study of the Non-Covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab in Patients With Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Diagnosis of MZL including splenic marginal zone lymphoma (SMZL), extra nodal marginal zone lymphoma (ENMZL) and nodal marginal zone lymphoma (NMZL), established by histologic assessment\n* Requiring treatment for MZL. Patients receiving prior systemic therapy as well as treatment naïve patients are eligible\n\n  * Local radiotherapy not exceeding a total dose of 20 Gy at least 2 weeks prior the first dose of study therapy is allowed\n* Radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy (as defined by Lugano Classification for non-Hodgkin lymphoma \\[NHL\\])\n\n  * Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed\n  * Subjects with skin extranodal marginal zone lymphoma (EMZL) who do not meet the radiographically measurable disease criteria described herein are eligible provided that skin lesion measures ≥ 1.5 cm in diameter and is documented by photo or there are multiple skin lesions measuring \\> 1cm in diameter on the body that cannot be incorporated in one radiation field and at least one of them is histologically confirmed as MZL\n  * Subjects with gastric extra nodal MZL histologically confirmed and need therapy but do not have measurable disease and in which response to treatment can be assess by multiple random gastric biopsies\n  * Subjects with conjunctival EMZL who do not meet the radiographically measurable disease criteria described herein are eligible provided that conjunctival lesion measures ≥ 1 cm in diameter and is documented by photo or there are multiple conjunctival lesions measuring together \\> 1 5cm that cannot be treated by radiation because of previous radiation therapy, contraindications to radiation and patient refusal to receive radiation therapy. At least one of these lesions needs be histologically confirmed as MZL\n* Willing to provide a lymph node or tissue biopsy from the most recent available archival tissue or undergo an incisional or excisional lymph node or tissue biopsy\n\n  * Subjects with splenic MZL who do not have a tumor to biopsy or an archival tumor tissue sample are eligible provided subject is willing to undergo a bone marrow biopsy or provide an archival bone marrow biopsy that was obtained before the date of the first dose of study treatment; bone marrow sample must show histologically confirmed infiltration of MZL\n* At least one of the following criteria for treatment initiation:\n\n  * Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm\n  * Any nodal or extra nodal tumor mass with a diameter of ≥ 5 cm\n  * B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \\> 10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement associated with the relapse\n  * Risk of local compressive symptoms that may result in organ compromise\n  * Splenomegaly or splenic lesion without splenomegaly\n  * Leukopenia attributed to MZL (leukocytes \\\u003C 1000\u002Fmm\\^3)\n  * Leukemia (\\> 5,000 lymphoma cells\u002Fmm\\^3)\n  * Threatened organ function, especially for extra nodal MZL\n  * Requirement for transfusion or growth factor support attributed to lymphoma\n  * Involvement of 2 or more extra nodal sites, with tumor\u002Flesion in each extra nodal site ≥ 1 cm\n  * Progression or relapsed within 24 months after MZL diagnosis in patients previously treated with ≥ 1 line of systemic therapy\n* Life expectancy \\> 3 months\n* Prior adverse events (AEs) must be resolved to grade 1\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 ≥ 50,000\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* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n\n  * Subjects with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver involvement by lymphoma\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver involvement by lymphoma\n* Creatinine clearance of ≥ 45 mL\u002Fmin\u002F1.73 m\\^2 using the Modification of Diet in Renal Disease formula OR ≥ 45 mL\u002Fmin by the Cockcroft-Gault formula\n* Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HBV or HCV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n\nPatients with occult or prior HBV infection (defined as negative hepatitis B virus surface antigen \\[HBsAg\\] and positive hepatitis B core antibody \\[HBcAb\\]) may be included if HBV deoxyribonucleic acid (DNA) is undetectable, if they are willing to undergo DNA testing on day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment\n\n* Participants with HIV are eligible if they meet ALL the following:\n\n  * CD4 count \\> 350 cells\u002FµL at screening\n  * The HIV viral load is below the detectable level as per locally available testing\n  * Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to study entry\n\n    * NOTE: ART includes drugs, which are NOT strong cytochrome P450 (CYP)3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study)\n  * HIV screening tests are not required unless:\n\n    * Known history of HIV infection\n    * As mandated by local health authority\n  * Are compliant with their ART\n\n    * NOTE: If the participant has had an AIDS defining opportunistic infection in the past 12 months prior to screening, they are not eligible to be included in the study\n* Person of childbearing potential (POCBP): 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* Participants assigned male sex at birth:\n\n  * If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n    * Nemtabrutinib: 12 days\n    * Rituximab: 3 months\n    * Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR\n    * Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:\n\n      * Uses a penile\u002Fexternal condom plus nonparticipant of childbearing potential who is not currently pregnant and should also be advised of the benefit for that partner to use an additional method of contraception, as a condom may break or leak\n      * Note: Participants capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use penile\u002Fexternal condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate\n    * Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed\n* Participants assigned female sex at birth:\n\n  * A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    * Is not a person of childbearing potential (POCBP) OR\n    * Is a POCBP and:\n\n      * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n        * Nemtabrutinib: 1 month\n        * Rituximab: 12 months\n      * The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n    * Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive\n    * Abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention with nemtabrutinib\n    * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy\n* Patients with gastrointestinal dysfunction and\u002For clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting or any other condition that will interfere significantly with drug absorption (e.g., gastric bypass surgery, gastrectomy)\n\nExclusion Criteria:\n\n* Evidence of diffuse large B-cell lymphoma (DLBCL) transformation\n\n  * Subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL\n* History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease\n* Active graft versus host disease\n* Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization)\n* Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment\n* Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of study treatment:\n\n  * \\\u003C 10 weeks from completion of any radio- or toxin-immunoconjugates\n  * \\\u003C 4 weeks for immunotherapy\n  * \\\u003C 3 weeks for radiotherapy\n  * \\\u003C 2 weeks for any investigational agent or other anticancer medications\n  * Steroids that are used for treatment of allergy or other underlying condition are permittable, but not steroids started to treat lymphoma. Subjects receiving corticosteroids must be at a dose level ≤ 10 mg\u002Fday within 7 days of the study treatment administration\n* Inadequate recovery from adverse events related to prior therapy to grade ≤ 1 (excluding grade 2 alopecia and neuropathy)\n* Prior non-covalent BTK inhibitor (prior covalent BTK inhibitors are allowed)\n* Major surgery (under general anesthesia) within 30 days prior to therapy initiation\n* Live vaccine within 30 days\n* Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks of the first day of study therapy\n* History of prior malignancy except:\n\n  * Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of therapy\n  * Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease\n  * Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease\n  * Asymptomatic prostate cancer managed with \"watch and wait\" strategy\n  * Superficial bladder cancer\n  * Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screening\n* History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding\n* Unstable cardiac disease as defined by one of the following:\n\n  * Acute myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III\n  * Unstable angina (angina symptoms at rest) or new-onset angina (begun within the last 3 months)\n  * Left ventricular ejection fraction (LVEF) \\\u003C 45%\n* Corrected QT interval (QTc) prolongation (defined as a Fridericia's formula-corrected QT interval \\[QTcF\\] \\> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin)\n* AIDS-defining opportunistic infection in the past 12 months prior to screening\n* History or concurrent condition of interstitial lung disease and\u002For severely impaired lung function\n* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study treatment\n* History of organ transplant\n* Known allergy\u002Fsensitivity to nemtabrutinib or any of the excipients; history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents\n* Clinically significant uncontrolled illness\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment\n* Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma\n* POCBP: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests the effect of nemtabrutinib in combination with rituximab in treating patients with marginal zone lymphoma. Nemtabrutinib, a non-covalent Bruton's tyrosine kinase (BTK) inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 nemtabrutinib in combination with rituximab may be safe, tolerable and\u002For effective in treating patients with marginal zone lymphoma.",[26,27,28,29,30,31,32],"Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma","Gastric Mucosa-Associated Lymphoid Tissue Lymphoma","Marginal Zone Lymphoma","Nodal Marginal Zone Lymphoma","Splenic Marginal Zone Lymphoma","Lymphoma","Extranodal Marginal Zone Lymphoma",[31],"NOT_YET_RECRUITING","2026-05-12",{"date":37,"type":38},"2026-05-15","ACTUAL",{"date":40,"type":20},"2026-12-16",{"date":42,"type":20},"2028-05-02",{"name":44,"class":45},"City of Hope Medical Center","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":46},"100559864","phase-2-mosunetuzumab-in-patients-with-newly-diagnosed-extranodal-marginal-zone-lymphoma-100559864","NCT06569680","Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma","Phase II Trial of Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma (EMZL) (ML44933)","Inclusion Criteria:\n\n1. Men and women aged 18 years or older at the time of signing informed consent.\n2. Able and willing to sign the informed consent form (ICF).\n3. Ability to comply with the trial protocol.\n4. Histologically confirmed EMZL presenting with stage I-IV disease.\n5. Previously untreated participants.\n\n   1. Participants with H. pylori-positive gastric EMZL who received an initial treatment with currently accepted antibiotics may be considered eligible if, after antibiotic regimen, participant has histologically confirmed MZL.\n   2. Participants who were previously treated with localized therapy (eg, radiation or surgery) and never received systemic therapy and present with recurrent disease are eligible upon histological confirmation of MZL.\n6. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 lesion that measures \\>1.5 cm in the longest diameter (LDi) and ≥1.0 cm in the longest perpendicular diameter as assessed by CT or MRI, especially in extranodal sites, per response criteria for lymphomas (Cheson, et al., 2014). Imaging must be conducted within 6 weeks prior to the start of therapy.\n\n   1. Participants with skin EMZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that skin lesion measures ≥1.5 cm in diameter by tape measure and is documented by photo or there are multiple skin lesions measuring \\>1 cm in diameter on the body and at least one of them is histologically confirmed as EMZL.\n   2. Participants with gastric EMZL histologically confirmed and need therapy but do not have measurable disease and in which response to treatment can be assessed by multiple random gastric biopsies per Groupe d'Etude des Lymphomes de l'Adult (GELA) criteria (Ruskoné Fourmestraux, et al., 2011).\n   3. Participants with conjunctival EMZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that conjunctival lesion measures ≥1 cm in diameter by tape measure and is documented by photo or there are multiple conjunctival lesions measuring together \\>1.5 cm. At least one of the lesions needs be histologically confirmed as EMZL.\n7. Participants must be willing to provide tissue biopsy from the most recent available archival tissue or undergo an incisional or excisional lymph node or tissue biopsy. If biopsy can be reviewed to confirm the diagnosis but there is no extra tissue for exploratory studies, such participants can still be enrolled in this trial.\n8. Participant should have at least one of the following criteria for treatment initiation:\n\n   * Threatened extranodal organ function\n   * Involvement of ≥3 nodal sites, each with diameter of ≥3 cm\n   * Any nodal or extranodal tumor mass with a diameter of ≥5 cm\n   * B symptoms (fever ≥38 degrees Celsius of unclear etiology, night sweats, weight loss \\>10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement associated with the relapse.\n   * Risk of local compressive symptoms that may result in organ compromise\n   * Splenomegaly or splenic lesion without splenomegaly\n   * Leukopenia attributed to MZL (leukocytes \\\u003C1000\u002Fmm3)\n   * Leukemia (\\>5,000 lymphoma cells\u002Fmm3)\n   * Requirement for transfusion or growth factor support attributed to lymphoma\n   * Involvement of 2 or more extranodal sites, with tumor\u002Flesion in each extranodal site ≥1 cm\n9. Life expectancy \\>3 months.\n10. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n11. Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):\n\n    * Absolute neutrophil count (ANC) ≥1.0 × 10\\^9\u002FL.\n    * Hemoglobin ≥8.0 g\u002FdL.\n    * Platelet count ≥ 75 × 10\\^9\u002FL.\n    * Total bilirubin ≤1.5 × upper limit normal (ULN). Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible.\n    * Alanine transaminase (ALT)\u002Faspartate aminotransferase (AST) ≤3.0 × ULN or ≤5 × ULN in the presence of liver involvement by lymphoma.\n    * Creatinine within normal institutional limits, or\n\n      * calculated creatinine clearance ≥30 mL\u002Fmin\u002F1.73 m2 using the Modification of Diet in Renal Disease formula\n      * calculated creatinine clearance ≥35 mL\u002Fmin by the Cockcroft-Gault Equation (Cockcroft, 1976)\n      * estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2 using the Modification of Diet in Renal Disease formula for participants with creatinine levels above institutional normal (unless due to lymphoma)\n12. Willingness to avoid pregnancy during the trial and for at least 90 days after the last dose of the trial intervention.\n\nExclusion Criteria:\n\n1. Evidence of diffuse large B cell lymphoma (DLBCL) transformation. Participants with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL.\n2. History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. Participants with Dural MZL are eligible.\n3. Patients that need immediate cytoreduction.\n4. Concurrent or previous anticancer therapy (eg, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).\n5. Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (\\>20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1.\n\n   1. Steroids that are used for treatment of allergy or other underlying condition are permittable, but not steroids started to treat lymphoma. Participants receiving corticosteroids must be at a dose level ≤20 mg\u002Fday within 7 days of the trial intervention administration.\n   2. The use of inhaled corticosteroids is permitted\n   3. The use of mineralocorticoids for management of orthostatic hypotension is permitted\n   4. Single dose of dexamethasone for nausea or B symptoms is permitted\n   5. Antibiotic treatment of H. pylori-positive gastric EMZL is permitted\n6. Allogeneic stem cell transplant, or autologous stem cell transplant or Chimeric antigen receptor T-cell therapy for any indication\n7. Active graft versus host disease.\n8. Inadequate recovery from toxicity and\u002For complications from a major surgery before starting therapy.\n9. Current or previous other malignancy within 3 years of trial entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.\n10. Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal (GI), endocrine, pulmonary, neurological, cerebral, or psychiatric disease.\n11. Chronic or current active infectious disease (including severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2)) requiring systemic antibiotics, antifungal, or antiviral treatment or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1\n12. Exposure to a live vaccine within 30 days of administration or anticipation that a live attenuated vaccine will be required during the study.\n\n    1. Inactivated influenza vaccinations may be given during the influenza season.\n    2. An approved coronavirus disease 2019 (COVID-19) vaccine (messenger ribonucleic acid (mRNA), inactivated virus, and replication deficient viral vector vaccines) is allowed.\n13. Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Note: HIV screening test is optional\n14. History of solid organ transplantation\n15. History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies (MAbs)\n16. Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the mosunetuzumab, lenalidomide, or thalidomide formulation, including mannitol.\n17. Significant cardiovascular disease (eg, New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 3 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)\n18. Known or suspected chronic active Epstein-Barr virus (EBV) infection\n19. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n20. History of progressive multifocal leukoencephalopathy (PML)\n21. Active hepatitis B infection\n\n    a. Patients who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive, must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation\n22. Active hepatitis C infection\n\n    a. Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation\n23. History of autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n\n    1. Patients with a remote history of, or well-controlled, autoimmune disease with a treatment free interval from immunosuppressive therapy for 12 months may be eligible to enroll if judged to be safe by the investigator\n    2. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible\n    3. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n    4. Patients with a history of disease-related immune thrombocytopenic purpura, or autoimmune hemolytic anemia may be eligible\n    5. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (eg, patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n       * i. Rash must cover 10% of body surface area\n       * ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n       * iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency oral corticosteroids within the previous 12 months\n24. Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.",{"count":19,"type":20},[23],"The purpose of this study is to test a new medication called Mosunetuzumab to see if it can help people with Extranodal Marginal Zone Lymphoma (EMZL). This study will include people who have not yet received any treatment for cancer and whose cancer is in stage I-IV. This study will help doctors understand if Mosunetuzumab improves outcomes in people with EMZL and if it is safe to use.",[32],"RECRUITING","2025-10-30",{"date":61,"type":38},"2025-11-03",{"date":63,"type":38},"2024-11-19",{"date":65,"type":20},"2030-12-01",{"name":67,"class":45},"Izidore Lossos, MD"]