To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi.
This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib (IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
25mg and/or 5mg oral capsule
1000mg/40mL single-use vials
Unnamed facility
La Jolla, California, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Hackensack, New Jersey, United States
Unnamed facility
New Hyde Park, New York, United States
Dose-limiting toxicities (DLTs)
Time frame: 28 days
Treatment-emergent adverse events (TEAEs)
Time frame: Up to 30 days from last dose of study treatment
Overall response rate (ORR)
Time frame: Up to 2 years from the first dose of study treatment
Duration of response (DOR)
Time frame: Up to 2 years from the first dose of study treatment
Progression-free survival (PFS)
Time frame: Up to 2 years from the first dose of study treatment
Overall survival (OS)
Time frame: Up to 2 years from the first dose of study treatment or until study treatment is completed, whichever is later
BTK mutation status
Time frame: Baseline
Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite)
Time frame: Week 1, Week 2, Months 2, 4, 7, 11, 15, 19
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Unnamed facility
Columbus, Ohio, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Montreal, Quebec, Canada