NCT04908228

Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Paolo Ghia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 multicenter national interventional pharmacological study aimed at determining the efficacy of a fixed duration treatment with ibrutinib and obinutuzumab in terms of uMRD in the BM at the end of treatment (+30 Days follow-up). Treatment with ibrutinib and obinutuzumab will be administered according to the following schedule: Ibrutinib 420 mg QD for 24 months (Cycles 1-24) Obinutuzumab starting from Cycle 13 Day 1 (100 mg Cycle 13 Day 1, 900 mg Cycle 13 Day 2, 1000 mg Cycle 13 Days 8 and 15, 1000 mg Cycles 14-18 Day 1). At the end of Cycle 24 all responding patients will discontinue ibrutinib and proceed with follow-up. If disease relapse occurs at any time after discontinuing treatment, ibrutinib therapy will be reintroduced at the standard dose of 420 mg QD and response to treatment monitored over time. Patients with stable (SD) or progressive disease (PD) at the end of Cycle 24, will continue ibrutinib as long as the treating physician deems they are benefiting from treatment and will be followed up in the study for survival and response to subsequent therapies.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Ibrutinib and obinutuzumab	Patients will receive fixed-duration treatment with ibrutinib and obinutuzumab.

Timeline

• Start date: 2021-12-13
• Primary completion: 2026-09-15
• Completion: 2027-09-15
• First posted: 2021-06-01
• Last updated: 2023-10-03

Locations

1 site across 1 country: Italy