NCT06967610

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).

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.

Detailed 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.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Leukemia (SLL)

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Given PO 200mg daily
DRUG	Venetoclax	Given PO daily
DRUG	Obinutuzumab	Given IV 100mg day 1, 900 mg day 2, 100mg days 8, 15

Timeline

• Start date: 2025-07-15
• Primary completion: 2031-06-01
• Completion: 2033-06-01
• First posted: 2025-05-13
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study