NCT05536349

Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the combination of pirtobrutinib (also called LOXO-305), venetoclax, and obinutuzumab is safe and effective when given to patients with chronic lymphocytic leukemia (CLL) or Richter transformation (RT) who have not previously received treatment.

Detailed description

Primary Objective: 1\. Estimate the therapeutic activity (undetectable measurable residual disease \[U-MRD\] rate) of combined pirtobrutinib, venetoclax, and obinutuzumab in patients with previously untreated CLL/SLL (cohort 1) by undetectable measurable residual disease (U-MRD) rate and Richter transformation (cohort 2) by overall response rate (ORR) (defined as CMR//PMR). Secondary Objectives: 1. To estimate the therapeutic activity of combination therapy by determining: 1. Combined response rate (defined as CR/CRi/PR) as assessed by the investigator for cohort 1 (CLL/SLL) 2. Progression free survival (PFS) and overall survival (OS). 3. U-MRD response with next generation sequencing assay for cohort 2 2. To determine the safety and tolerability of this combination therapy Exploratory Objective: 1. To study immunological and molecular changes in the peripheral blood and bone marrow in response to pirtobrutinib, venetoclax, and obinutuzumab. 2. To evaluate the kinetics of MRD response over time

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Given by PO
DRUG	Obinutuzumab	Given by (IV) vein
DRUG	Venetoclax	Given by PO
DRUG	Valacyclovir	Given by PO
DRUG	Allopurinol	Given by PO

Timeline

• Start date: 2022-12-20
• Primary completion: 2028-04-25
• Completion: 2028-04-25
• First posted: 2022-09-10
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study