A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to learn if the combination of zanubrutinib, sonrotoclax, and obinutuzumab can help to control previously untreated CLL/SLL.
Description
Primary Objective: 1\. To evaluate the therapeutic activity, measured by U-MRD4 rate (assessed by clonoSEQ assay) in the bone marrow after cycle 15 of the combination of zanubrutinib, sonrotoclax, and obinutuzumab in patients with previously untreated CLL/SLL. Secondary Objectives: 1. To evaluate the therapeutic activity of the combination of zanubrutinib, sonrotoclax, and obinutuzumab by determining the overall response rate (defined as CR/CRi/PR) and U-MRD5/UMRD6 rate. 2. To evaluate progression free survival (PFS). 3. To evaluate overall survival (OS). 4. To determine the safety and tole…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with a diagnosis of previously untreated CLL/SLL meeting iwCLL 2018 indication for treatment (Note: patients who receive steroids and/or CD20 mAb for cytoreduction in those patients presenting with significantly elevated WBC count or significant adenopathy/organomegaly and those who previously received steroids/CD20 mAb for immune cytopenias are eligible to enroll; Washout of 3 months applies for CD20 mAb and dose of prednisone (or equivalent) should be less than 20 mg/day by day 1 of study initiation) 2. Age greater than or equal to 18 years of age 3. Eastern…
Interventions
- DrugZanubrutinib
Given orally
- DrugObinutuzumab
Given orally
- DrugSonrotoclax
Given orally
Location
- UT MD AndersonHouston, Texas