[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ann-arbor-stage-iv-follicular-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ann-arbor-stage-iv-follicular-lymphoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100550085","phase-2-low-dose-mosunetuzumab-for-the-treatment-of-patients-with-indolent-b-cell-lymphoma-100550085",false,"NCT06442475","Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma","Low Dose Mosunetuzumab for Indolent B-Cell Lymphoma","Inclusion Criteria:\n\n* 18 years or older at time of signing informed consent\n* Capable of understanding and providing written informed consent\n* Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior therapy for lymphoma. (Prior peptide-based therapeutic vaccines are allowed.) Eligible histologies include:\n\n  * Follicular lymphoma (grade 1-2 or 3A)\n  * Marginal zone lymphoma\n* Ann Arbor stage II-IV disease\n* No prior therapy for lymphoma\n* Have low-tumor burden disease, defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:\n\n  * Nodal or extranodal tumor mass \\\u003C 7 cm\n  * Involvement of less than 3 nodal sites with a diameter \\> 3 cm\n  * No systemic or B symptoms\n  * No splenomegaly \\> 16 cm by imaging\n  * No local risk of vital organ compression\n  * No pleural or peritoneal serous effusions\n  * No leukemic phase (\\> 5,0000\u002F uL circulating lymphocytes)\n  * No significant cytopenias defined as platelets \\\u003C 100,000\u002FuL, hemoglobin \\\u003C 10 g\u002FdL, or absolute neutrophil count (ANC) \\\u003C 1500\u002F uL\n* Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose F-18 (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Creatinine clearance ≥ 50 mL\u002Fmin calculated by Cockcroft-Gault equation\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome who may have a total bilirubin up to ≤ 3 x ULN\n* Aspartate aminotransferase (AST) ≤ 3 x the ULN\n* Alanine aminotransferase (ALT) ≤ 3 x the ULN\n* Gamma glutamyl transferase (GGT) ≤ 3 x the ULN\n* Negative serum or urine pregnancy test within 7 days of initiating mosunetuzumab for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year\n* Fertile male and woman of childbearing potential must agree to use highly effective contraceptive methods from start of treatment to at least 3 months after the last dose of mosunetuzumab\n\nExclusion Criteria:\n\n* History of severe allergic reaction to monoclonal antibody therapy\n* History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the principal investigator (PI) may be included\n* Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment\n* Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HbBsAg\\] serology):\n\n  * Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standards\n* Autoimmune disease requiring active therapy\n* History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)\n* Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg\u002Fday of prednisone or equivalent\n* Prior use of any monoclonal antibody within 4 weeks before the first mosunetuzumab administration\n* Prior solid organ transplantation\n* Pregnant or breast-feeding women, or intending to become pregnant during the study or within 3 months of the last dose of mosunetuzumab","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.",[26,27,28,29,30,31,32,33,34],"Ann Arbor Stage II Follicular Lymphoma","Ann Arbor Stage II Marginal Zone Lymphoma","Ann Arbor Stage III Follicular Lymphoma","Ann Arbor Stage III Marginal Zone Lymphoma","Ann Arbor Stage IV Follicular Lymphoma","Ann Arbor Stage IV Marginal Zone Lymphoma","Grade 1 Follicular Lymphoma","Grade 2 Follicular Lymphoma","Grade 3a Follicular Lymphoma","RECRUITING","2026-03-10",{"date":38,"type":39},"2026-03-13","ACTUAL",{"date":41,"type":39},"2024-08-29",{"date":43,"type":20},"2027-02-12",{"name":45,"class":46},"University of Washington","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":47},"100552334","phase-2-combination-of-zanubrutinib-rituximab-and-venetoclax-in-patients-with-previously-untreated-follicular-lymphoma-100552334","NCT06471738","Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma","Safety and Efficacy of Zanubrutinib in Combination With Rituximab and Venetoclax in Previously Untreated Follicular Lymphoma: An Open Label, Phase 2 Study","Inclusion Criteria:\n\n* A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated\n* Stage II, III, or IV disease\n* Able and willing to provide written informed consent and to comply with the study protocol\n* at least one measurable disease\n* Must be in need of therapy as evidenced by at least one of the following criteria:\n* Presence of at least one B symptom:\n\n  * Fever (\\> 38 Celsius \\[C\\]) not due to infectious etiology\n  * Night sweats\n  * Weight loss \\> 10% in the past 6 months\n* Fatigue due to lymphoma\n* Splenomegaly (\\> 13 cm)\n* Compression syndrome (ureteral, orbital, gastrointestinal)\n* Any of the following cytopenias, due to lymphoma:\n\n  * Hemoglobin ≤ 10 g\u002FdL\n  * Platelets ≤ 100 x 10\\^9\u002FL\n  * Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL\n* Pleural or peritoneal effusion\n* Lactate dehydrogenase (LDH) \\> upper limit of normal (ULN) or beta (B)2 microglobulin \\> ULN\n* Other lymphoma-mediated symptoms as determined by the treating physician\n\nExclusion Criteria:\n\n* ECOG≤ 2\n* Absolute neutrophil count (ANC) \\> 1.0 x 10\\^9\u002FL\n* Platelet count \\> 50 x 10\\^9\u002FL\n* Prothrombin time (PT)\u002Finternational normal ratio (INR) \\\u003C 1.5 x (upper limit of normal) ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time \\[aPTT\\]) \\\u003C 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder). When treated with warfarin or other vitamin K antagonists, then INR ≤ 3.0)\n* Serum aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C 3 x upper limit of normal (ULN)\n* Creatinine clearance \\> 30 ml\u002Fmin calculated by modified Cockcroft-Gault formula\n* Bilirubin \\\u003C 1.5 x ULN unless bilirubin is due to Gilbert's syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g\u002FdL\n* Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \\[B-hCG\\]) pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study\n\nExclusion Criteria:\n\n* Known active central nervous system lymphoma or leptomeningeal disease\n* Follicular lymphoma with evidence of diffuse large B-cell transformation\n* Grade 3b follicular lymphoma\n* Any prior history of other malignancy besides follicular lymphoma\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy\n* Patients who have undergone major surgery within 14 days\n* The researchers believe that it is not advisable for the participant to take part in this trial.",{"count":56,"type":20},30,[23],"This is a single center, open label, single arm phase II clinical trial. The objective of this study is to assess the feasibility and efficacy of zanubrutinib combined with venetoclax and Rituximab in patients with previously untreated follicular lymphoma (FL) .",[26,32,28,30,33,34],"2024-07-16",{"date":62,"type":39},"2024-07-18",{"date":64,"type":39},"2024-07-10",{"date":66,"type":20},"2027-06-01",{"name":68,"class":46},"Chinese PLA General Hospital"]