This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL/SLL who have previously been treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
Arizona Oncology
Tempe, Arizona, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
Moores UC San Diego Cancer Center
La Jolla, California, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Overall Response Rate (ORR)
Time frame: From start of treatment to first documented response, 2 cycles (58 days)
Treatment-Emergent adverse events (TEAEs) and changes in laboratory values
Time frame: From start of treatment to end of treatment plus 30 days; 7 months
Duration of response (DOR), defined as the time from the first documentation of response to the first documentation of PD or death due to any cause
Time frame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months
Progression-free survival (PFS), defined as the time from the first dose of study treatment to the first documentation of PD or death from any cause
Time frame: Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months
Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks
Time frame: Greater than or equal to 8 weeks
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QUEST Research Institute
Royal Oak, Michigan, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Summit Medical Group
Morristown, New Jersey, United States
Medical Oncology Associates PS, WA
Spokane, Washington, United States