A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)

Status: Active

Description

This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of PI3K-δ,γ, in patients with relapsed or refractory Peripheral T cell Lymphoma (PTCL).

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years of age
  • Diagnosis of one of the following histologic subtypes of PTCL, pathologically-confirmed, as defined by the World Health Organization:
  • Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS);
  • Angioimmunoblastic T-cell lymphomas (AITL);
  • Anaplastic large cell lymphoma (ALCL); or
  • Natural-killer/T-cell lymphoma (NKTL)
  • Received at least 2 cycles of one prior regimen administered with curative intent and one of the following:
  • failed to achieve at least a partial response after 2 or more cycles;
  • failed to achieve a complete response after 6 or more cycles; and/or
  • progressed after an initial response
  • For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
  • Measurable disease as defined by IWG for PTCL, i.e., at least 1 measurable disease lesion > 1.5 cm in at least one dimension by 18FDG-PET-CT, MRI, or diagnostic CT

Exclusion Criteria

  • Clinical evidence of transformation to a more aggressive subtype of lymphoma
  • Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
  • Known central nervous system involvement by PTCL
  • Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) once daily (QD)
  • Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Approved
Contact: April Johnson
Phone: 949-653-2959ext118
Email: AprilDJohnson@mednet.ucla.edu
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Approved
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: In review
Name Not Available

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Contact: Neha Mehta-Shah
Phone: 314-747-7955
Email: mehta-n@wustl.edu

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Steven Michael Horwitz
Phone: 212-639-3045
Email: horwitzs@mskcc.org

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: In review
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Verastem Inc

Trial IDs

Primary ID VS-0145-225
Secondary IDs NCI-2018-00275
Clinicaltrials.gov ID NCT03372057