A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL. The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Palo Alto, California, United States
Unnamed facility
Hackensack, New Jersey, United States
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
Time frame: 28 days from first dose of study treatment
Complete Response Rate (CRR)- Part 2
Time frame: Up to 2 years from the first dose of study treatment
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as \>=Grade 3.
Time frame: Up to 30 days after the 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)
The median DOR was non-estimable.
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
Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Time frame: Every 4 weeks for 16 weeks
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Unnamed facility
Rochester, New York, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Kortrijk, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Wilrijk, Belgium
Unnamed facility
Clermont-Ferrand, France
Unnamed facility
Marseille, France
...and 11 more locations