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

NCT03372057 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-03-07

Study results available
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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).

Conditions

  • Peripheral T-cell Lymphoma

Interventions

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).

Sponsors & Collaborators

  • SecuraBio

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2023-12-22
Completion
2023-12-22
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Italy
  • Japan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03372057 on ClinicalTrials.gov