A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Peripheral T Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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: 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...
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: 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.
Tracking Information
- NCT #
- NCT03372057
- Collaborators
- Not Provided
- Investigators
- Study Director: David Cohan, MD SecuraBio Chief Medical Officer
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