Status:
RECRUITING
Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Paolo Ghia
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, multicenter, open-label uncontrolled interventional study aimed a determining therapeutic benefits of the addition of ibrutinib to 12 months of venetoclax (single-agent for 6 months...
Eligibility Criteria
Inclusion
- Age ≥18 years but \<65 years
- Active CLL/SLL requiring treatment per iwCLL 2018 criteria
- No previous therapy for CLL/SLL
- Adequate bone marrow function:
- ANC ≥1.0 x 109/L;
- Plt ≥25 x 109/L;
- Hgb ≥8.0 g/dl
Exclusion
- Any prior therapy used for treatment of CLL or SLL
- History of other malignancies, except in situ carcinoma or malignancy treated with curative intent
- Known or suspected history of Richter's transformation
- Known hypersensitivity to one or more study drugs
- Inadequate renal function: CrCl \<30 mL/min
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
- Requires the use of warfarin or derivatives
- Treatment with any of the following within 7 days prior to the first dose of study drug:
- Steroid therapy for anti-neoplastic intent
- Moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix G for examples)
- Moderate or strong CYP3A inducers (see Appendix G for examples)
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04758975
Start Date
September 19 2022
End Date
December 30 2027
Last Update
October 4 2023
Active Locations (1)
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1
IRCCS Ospedale San Raffaele
Milan, MI, Italy, 20132