[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558915":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":47,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":45,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":45,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":45,"overallStatus":73,"whyStopped":45,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":45},{"fullName":5,"class":6},"Fox Chase Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL","This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of Measurable Residual Disease (MRD) adapted duration of BR for untreated or R\u002FR iNHL (indolent non-hodgkin lymphoma). All patients will receive Bendamustine 90 mg\u002Fm2 IV on Days 1-2 and Rituximab 375 mg\u002Fm2 IV(BR) on Day 1 of each cycle. Each cycle will last 28 days. On day 1 of each cycle, patients will receive Rituximab before Bendamustine, and CBC (complete blood count), CMP (comprehensive metabolic panel) will be obtained to capture any hematologic toxicities as well as clonoSEQ testing to determine MRD status. After completing Cycle 3, imaging results (with confirmatory biopsy if applicable) and the clonoSEQ MRD testing results obtained from ctDNA (blood collection) will determine whether patients will receive Cycles 5 and 6 of Bendamustine and Rituximab (BR).",[13,14],"Drug: Bendamustine","Drug: Rituximab",[16,26],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Bendamustine","Bendamustine will be administered as 10 minute IV infusion at 90 mg\u002Fm2 (drug dose calculation is based on treatment day weight) on days 1 and 2 for 4-6 cycles (number of cycles determined per treatment design). Subjects will be dosed every 28 days. Ondansetron 16 mg IV is given as premedication per institutional guidelines. Dose modifications will be determined based on renal and hepatic function. Subjects should be carefully monitored for infusion reactions during Bendamustine administration. If an acute infusion reaction is noted, subjects should be managed according to institutional guidelines. Doses of Bendamustine may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment based on physician discretion.",[9],[22,23,24,25],"cytostasan","belrapzo","treanda","vivimusta",{"type":17,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Rituximab","Rituximab will be administered as an IV infusion at 375 mg\u002Fm2 (longer for the first dose) (drug dose calculation is based of treatment day weight) on day 1 for 4-6 cycles (number of cycles determined per treatment design). Infusion rate will be determined as per institutional standards. Subjects will be dosed every 28 days. Diphenhydramine 50 mg IV and acetaminophen 650 mg are required to be given to the subjects within 30 minutes prior to Rituximab dose. There are no dose modifications recommended with Rituximab. If an acute infusion reaction is noted, subjects should be managed according to institutional guidelines. Doses of Rituximab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment.",[9],[31,32,33,34,35],"riabni","Rituxan","Ruxience","Truxima","Azulfidine",[37],{"name":38,"affiliation":5,"role":39},"Marcus Messmer","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Abigail O'Keefe","CONTACT","215-728-2451",null,"abigail.o'keefe@fccc.edu",{"type":48,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[50],{"name":51,"class":52},"Adaptive Biotechnologies","INDUSTRY","100558915","phase-2-mrd-guided-de-intensification-of-bendamustinerituximab-for-indolent-non-hodgkin-lymphoma-100558915",false,"NCT06557330","MRD Guided De-intensification of Bendamustine\u002FRituximab for Indolent Non-Hodgkin Lymphoma","HM-225: Measurable Residual Disease (MRD) Guided De-intensification of Bendamustine\u002FRituximab (BR) for Indolent Non-Hodgkin Lymphoma","Inclusion Criteria:\n\nPatients must have pathologically confirmed:\n\n* indolent Non-Hodgkin Lymphoma, consistent with one of the below diagnoses:\n* Follicular Lymphoma (Grade 1-3a)\n* Marginal Zone Lymphoma\n* Lymphoplasmacytic Lymphoma\n\nPatient may be treatment naïve or relapsed\u002Frefractory without having received prior Bendamustine or patients recently started on Bendamustine 90 mg\u002Fm2 with Rituximab 375 mg\u002Fm2 are eligible if C2D1 BR is no more than 14 days prior to enrollment and they otherwise meet eligibility criteria\n\n* Age \\> 18 years\n* ECOG performance status 0-2\n\nPatients must have normal organ and marrow function as defined below:\n\n* Absolute Neutrophil Count \\>1000mm3 and Hemoglobin \\>8 g\u002FdL (unless due to bone marrow involvement by lymphoma)\n* Total bilirubin \\> 1.5x upper limit of normal (patients with Gilbert's syndrome can have total bilirubin up to 3x upper normal limit)\n* Aspartate aminotransferase\u002F alanine aminotransferase (serum glutamic-oxaloacetic transaminase\u002F serum glutamic-pyruvic transaminase) \\\u003C 5 times institutional normal limits\n* Creatinine clearance \\> 30 Ml\u002Fmin\n\nExclusion Criteria:\n\n* Radiation or systemic treatment for lymphoma within the past 28 days prior to cycle 1 day 1 of BR.\n* Patients with pathologically confirmed transformed lymphoma, including diffuse large B cell lymphoma or other high grade lymphomas\n* Patients on active treatment for second malignancy with the exception of endocrine therapy for non-metastatic breast cancer, hormone therapy for prostate cancer, or local treatment for non-melanoma skin cancer.\n* Pregnant or breast-feeding. Refer to section 5.4 for further detail.\n* Failure to identify a dominant clonal sequence with ClonoSEQ from pre-treatment specimen or inadequate tissue for testing","ALL","18 Years","99 Years",{"count":64,"type":65},24,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of MRD adapted duration of BR for untreated or R\u002FR iNHL.",[71,72],"Lymphoma","Indolent Non-hodgkin Lymphoma","NOT_YET_RECRUITING","2025-01-03",{"date":76,"type":77},"2025-01-06","ACTUAL",{"date":79,"type":65},"2025-06",{"date":81,"type":65},"2028-03-30",{"name":5,"class":6}]