NCT03372057

A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Duvelisib	Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
DRUG	Duvelisib	Duvelisib PO 75 mg BID in 28-day cycles.
DRUG	Duvelisib	Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase).

Timeline

• Start date: 2018-02-22
• Primary completion: 2023-12-22
• Completion: 2023-12-22
• First posted: 2017-12-13
• Last updated: 2025-03-07
• Results posted: 2025-02-28

Locations

36 sites across 5 countries: United States, Germany, Italy, Japan, United Kingdom

Regulatory

• FDA-regulated drug study