Actively Recruiting
Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL
Led by Paolo Ghia · Updated on 2023-10-03
53
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) meeting iwCLL criteria
- Previously untreated active disease requiring treatment per iwCLL criteria
- ECOG performance status 0 or 1
- Measurable lymph node disease larger than 1.5 cm by CT scan
- Adequate blood function: neutrophils >750 cells/µL, platelets >30,000/µL, hemoglobin >8.0 g/dL
- Adequate liver and kidney function: AST or ALT ≤3x upper limit of normal, creatinine clearance ≥30 mL/min, bilirubin ≤1.5x upper limit of normal (except Gilbert's syndrome or non-hepatic causes)
- Prothrombin time (PT)/INR <1.5x upper limit of normal and aPTT <1.5x upper limit of normal unless unrelated to bleeding disorders
You will not qualify if you...
- Any prior therapy for CLL or SLL including chemotherapy, targeted therapy, immunomodulating therapy, radiotherapy, or monoclonal antibodies
- Presence of del(17p) and/or TP53 mutation
- History of other cancers except those treated with curative intent and no active disease for 3 or more years, adequately treated non-melanoma skin cancer, or carcinoma in situ without evidence of disease
- Known or suspected Richter's transformation
- Known allergy to study drugs
- Known bleeding disorders such as von Willebrand's disease or hemophilia
- Stroke or intracranial hemorrhage within 6 months prior to enrollment
- Known HIV infection or active hepatitis B or C infection; patients positive for hepatitis B or C antibodies must have negative PCR test
- Unable to swallow capsules/tablets or have gastrointestinal conditions affecting absorption
- Use of warfarin or vitamin K antagonists
- Major surgery within 4 weeks before first dose of study drug
AI-Screening
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Trial Site Locations
Total: 1 location
1
Strategic Research Program on CLL
Milan, MI, Italy, 20132
Actively Recruiting
Research Team
P
Paolo Ghia, MD, PhD
CONTACT
E
Eloise Scarano, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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