NCT02242942

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 445 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years

Conditions

• Lymphocytic Leukemia, Chronic

Interventions

Type	Name	Description
DRUG	Chlorambucil	Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.
DRUG	Venetoclax	Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.
DRUG	Obinutuzumab	Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6

Timeline

• Start date: 2014-12-31
• Primary completion: 2018-08-17
• Completion: 2025-08-27
• First posted: 2014-09-17
• Last updated: 2025-11-06
• Results posted: 2019-10-01

Locations

122 sites across 21 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Croatia, Denmark, Estonia, France, Germany, Italy, Mexico, New Zealand, Poland, Romania, Russia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study