Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
M.D. Anderson Cancer Center
Summary
To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.
Description
Primary Objective: \- Rate of bone marrow undetectable Measurable Residual Disease (10-4 sensitivity; uMRD4) at end of Cycle 13. Secondary Objectives: * Blood uMRD6 rate at end of cycles 9, 13, 19, 25. * 2018 iwCLL response rates defined as complete response (CR), CR with incomplete count recovery (CRi), partial response (PR), overall response (OR), stable disease (SD), and progressive disease (PD) at cycle 13. * Progression-free (PFS) and overall survival (OS); time to blood uMRD6 relapse; safety and tolerability.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria: 1. Age 18 years or older. 2. Diagnosis of CLL/SLL per 2018 iwCLL criteria (See Appendix 1). 3. Participants with previously treated CLL requiring therapy based on 2018 iwCLL criteria. 4. The participant is able to take oral medications. 5. Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. 6. Prior or ongoing therapy with covalent BTKi is allowed, but not required. 7. Prior or ongoing therapy (at least for six months) with BCL2i is allowed, b…
Interventions
- DrugPirtobrutinib
Given PO 200mg daily
- DrugVenetoclax
Given PO daily
- DrugObinutuzumab
Given IV 100mg day 1, 900 mg day 2, 100mg days 8, 15
Location
- MD Anderson Cancer CenterHouston, Texas