NCT04447768

The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)

A Phase II: Venetoclax-Based Therapy for the Treatment of Fit Patients With Chronic Lymphocytic Leukemia (CLL) in the Front-Line Setting

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will help researchers collect more information about how effective the combination of venetoclax and obinutuzumab is in treating CLL in people who have not received a previous treatment for their cancer.

Conditions

• Chronic Lymphocytic Leukemia (CLL)

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Cycle 1, Day 1- 100 mg Cycle 1, Day 2 - 900 mg Cycle 1, Day 8 - 1000 mg Cycle 1, Day 15 -1000 mg Cycle 2, Day 1 to Cycle 6, Day 1- 1000 mg
DRUG	Venetoclax	Cycle 1, Day 22 to 28 -20 mg daily Cycle 2, Day 1 to Day 7 -50 mg daily Cycle 2, Day 8 to Day 14- 100 mg daily Cycle 2, Day 15 to Day 21- 200 mg daily Cycle 2, Day 22 to Day 28 - 400 mg daily Cycle 3, Day 1 to end of Cycle 12-24 - 400 mg daily

Timeline

• Start date: 2020-12-03
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2020-06-25
• Last updated: 2025-10-14

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study