Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL
Status:
Not yet recruiting
Trial end date:
2027-09-15
Target enrollment:
Participant gender:
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.