MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma
NCT Number: NCT06557330
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma|Indolent Non-hodgkin Lymphoma
Interventions: DRUG: Bendamustine|DRUG: Rituximab
Sponsor: Fox Chase Cancer Center
Collaborators: Adaptive Biotechnologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-27
Completion Date: 2027-09-30

Summary:
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/R iNHL.

Primary Outcome Measures: PFS Evaluation, To evaluate the 2-year progression free survival (PFS) for patients treated with Bendamustine and Rituximab (BR) with measurable residual disease directed (MRD) duration of therapy., 2 years|Statistical PFS, The proportion (p) of patients who are progression-free and are alive at 2 years from the initiation of treatment using Lugano Criteria., 2 years
Secondary Outcome Measures: Secondary Outcome Measure, Assess additional clinical outcomes including overall survival (OS),, 2 years|Measurable Residual Disease Evaluation, To determine the rate of MRD (minimal residual disease) negativity at end of treatment and at 2 years post-treatment, 2 years|Adverse Event assessment, Assess adverse effects of treatment, 2 years|Overall Survival Assessment, OS, defined as time from initiation of study treatment until death, or the end of follow-up, whichever occurs first. Patients who are still alive at the end of follow-up will be considered censored., 2 years|Measurable Residual Disease Negativity, To evaluate MRD negativity rate at the end of treatment and at 2 years post-treatment., 2 years|Rate of 3+ adverse events, The rate of grade 3+ adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.The rate of grade 3+ adverse events as assessed by CTCAE v5.0., 2 years
Other Outcome Measures: Exploratory Outcome Measures, Assess and compare measurable residual disease (MRD) sensitivity of both circulating tumor DNA (ctDNA) and circulating tumor cells (CTC), both being obtained at baseline, after each cycle, and during follow up, 2 years|Measurable Residual Disease (MRD), Assess MRD level, both ctDNA and circulating tumor cell (CTC) testing, after each cycle of Bendamustine and Rituximab (BR) and correlate with Progression Free Survival (PFS), 2 years|Progression Free Survival (PFS) for Measurable Residual Disease (MRD), To evaluate PFS for patients with low level detectable MRD (10\^-4 to 10\^-6) after 3 cycles of Bendamustine and Rituximab, 2 years|Measurable Residual Disease (MRD) to guide indolent lymphoma treatment evaluation, Evaluate feasibility of using MRD to guide treatment for indolent lymphoma, 2 years|Measurable Residual Disease (MRD) failure rate, Determine MRD test baseline failure rate from ctDNA and Circulating Tumor Cell (CTC) testing, 2 years|Infection occruance, Assess occurrence of infection of any grade, 2 years|Secondary malignancy occurrence, Assess occurrence of secondary malignancy, 2 years|Ntural Killer and T cell reconstitution, Assess the rate of NK (natural kiler) cell and T cell subset reconstitution after Bendamustine and Rituximab; distinguish if there is difference between shorter/longer treatment regimens, 2 years|Quality Life Assessment, Assess differences in quality of life based on Functional Assessment of Cancer Therapy (FACT-Lym) questionnaire between patients who received varying lengths of treatment., 2 years|Baseline Proliferative Rate, Correlation of baseline proliferative rate, 2 years