This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of phosphoinositide-3-kinase-delta, gamma (PI3K-δ,γ), in participants with relapsed/refractory peripheral T-cell lymphoma (PTCL).
The study had 2 phases, a Dose Optimization Phase and an Expansion Phase. In the Dose Optimization Phase, participants were randomly assigned to 1 of 2 study cohorts, as follows: * Cohort 1: Duvelisib per oral (PO) twice daily (BID) at a starting dose of 25 milligrams (mg), with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles. * Cohort 2: Duvelisib 75 mg PO BID, administered in 28-day cycles. A total of 20 participants were to be enrolled in the Dose Optimization Phase, with 10 participants per cohort. Based on the safety and activity data obtained in the Dose Optimization Phase of the study, the Expansion Phase dose of duvelisib was to be determined. In the Expansion Phase, approximately 100-130 participants were to be enrolled and receive duvelisib dose in 28-day cycles as determined in Dose Optimization Phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria
ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.
Time frame: 56 days (2 cycles; 28-day cycles)
ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria
ORR was defined as the percentage of participants with CR + PR, as assessed by the IRC using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.
Time frame: 56 days (2 cycles; 28-day cycles)
Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria
DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of progressive disease (PD) or death due to any cause. Participants who withdraw from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.
Time frame: Up to 70 months
Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria
PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.
Time frame: Up to 70 months
Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria
DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of stable disease (SD) sustained for at least 8 weeks.
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City of Hope National Medical Center
Duarte, California, United States
University of California - Irvine
Irvine, California, United States
University of California - Los Angeles
Los Angeles, California, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
...and 26 more locations
Time frame: Up to 8 weeks
DOR as Assessed by the IRC Using the Lugano Criteria
DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of PD or death due to any cause. Participants who withdrew from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.
Time frame: Up to 70 months
PFS as Assessed by the IRC Using the Lugano Criteria
PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.
Time frame: Up to 70 months
DCR as Assessed by the IRC Using the Lugano Criteria
DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of SD sustained for at least 8 weeks.
Time frame: Up to 8 weeks
Overall Survival (OS)
OS was defined as the time from the date of first treatment to the date of death due to any cause. Participants without documented death were censored at last alive date.
Time frame: Up to 70 months
Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)
Blood samples were taken for the analyses of duvelisib and IPI-656 in plasma at designated time points. Results are reported as nanograms/milliliter (ng/mL).
Time frame: Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)