This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of PI3K-,, 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, as follows:
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.
|Clinical Study Identifier||NCT03372057|
|Last Modified on||8 October 2020|
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