A Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive Measurable Residual Disease
M.D. Anderson Cancer Center
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.
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) wit…
Eligibility
- Age range
- 80+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants are eligible to be included in the study only if ALL the following criteria apply: 1. Age ≥18 years at the time of signing the Informed Consent Form 2. Ability to comply with the study protocol and procedures and required 3. Patients must have received ≥2 prior lines of systemic therapy, including the current BTKi 4. Patients with high-risk CLL/SLL defined as the presence of any of the following factors: progression of disease on prior covalent BTKi, or progression of disease on or within 6 months of venetoclax-based treatment, or 3 or more prior treatments,…
Interventions
- DrugMosunetuzumab
Given by injection
Location
- UT MD AndersonHouston, Texas