Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL
Recruiting
Phase 2
Interventional Study
Chronic Lymphocytic Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 53 (estimated)
- Sponsor
- Paolo Ghia · Other
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About This Trial
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) Obinu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years
2. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets iwCLL diagnostic criteria
3. Previously untreated active disease requiring treatment per iwCLL criteria
4. ECOG PS 0 or 1
5. Measurable lymph node disease (\>1.5 cm…
Contacts