A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
18 Years and older, Male and Female
This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of PI3K-d,?, in patients with relapsed or refractory Peripheral T cell Lymphoma (PTCL).
The study has 2 phases, a Dose Optimization Phase and an Expansion Phase.
In the Dose Optimization Phase, patients will be randomly assigned to 1 of 2 study cohorts,
- Cohort 1: Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a
per-patient basis to 50 mg and then 75 mg, based on the patient'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 patients will be enrolled in the Dose Optimization Phase, with 10 patients per
cohort. Based on the safety and activity data obtained in the Dose Optimization Phase of the
study, the Expansion Phase dose of Duvelisib will be determined.
In the Expansion Phase, approximately 90-100 patients may be enrolled and will receive
Duvelisib dose in 28-day cycles as determined in Dose Optimization Phase.