Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive MRD
brief summary
The purpose of this study is to assess the therapeutic efficacy of mosunetuzumab, a bispecific antibody targeting CD20 and CD3 in patients who have detectable chronic lymphocytic leukemia (CLL) after receiving Bruton's tyrosine kinase inhibitors (BTKis) for at least 6 months and have no clinical or laboratory evidence of disease progression.
detailed description
Primary Objective:
The primary objective is to assess the activity of mosunetuzumab in eliminating MRD when added to continuous BTKi therapy. The primary endpoint will be the rate of undetectable MRD4 (uMRD4) in the bone marrow, using ClonoSEQ at the end of Cycle 17 of mosunetuzumab treatment. The target bone marrow uMRD4 rate at the end of Cycle 17 is 50%.
Secondary Objectives:
* Assessment of safety and tolerability of mosunetuzumab when added to continuous BTKi therapy * Proportion of patients who stop all treatment after C17 assessment * Elimination of residual lymph nodes (≥1.5 cm) with mosunetuzumab * Clinical response rates (ORR, CR, PR) at the end of Cycle 17 * MRD clearance by ClonoSEQ (uMRD6) at the end of Cycle 8 of mosunetuzumab treatment * Assessment of PFS and OS * uMRD4 and uMRD6 rates in blood and bone marrow at end of Cycle 17 * uMRD4 and uMRD6 rates in blood and bone marrow and clinical response rates at end of cycle 17, stratified by TP53/del(17p)/IGHV status, prior venetoclax treatment, line of therapy * uMRD4 and uMRD6 status every 6 months after end of combined treatment for 3 years * Assessment of MRD kinetics in peripheral blood and bone marrow at serial time points
official title
A Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive Measurable Residual Disease