Summary

for people ages 18 years and up (full criteria)
at Irvine, California and other locations
study started
estimated completion
Lauren Pinter-Brown, MD

Description

Summary

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).

Official Title

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)

Details

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.

Keywords

Peripheral T-cell Lymphoma Lymphoma T-cell Lymphoma Relapse Refractory PI3K-δ,γ Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Duvelisib

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥ 18 years of age
  2. Diagnosis of one of the following histologic subtypes of PTCL, pathologically-confirmed, as defined by the World Health Organization:
  3. Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS);
  4. Angioimmunoblastic T-cell lymphomas (AITL);
  5. Anaplastic large cell lymphoma (ALCL); or
  6. Natural-killer/T-cell lymphoma (NKTL)
  7. Received at least 2 cycles of one prior regimen administered with curative intent and one of the following:
  8. failed to achieve at least a partial response after 2 or more cycles;
  9. failed to achieve a complete response after 6 or more cycles; and/or
  10. progressed after an initial response
  11. For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
  12. 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

You CAN'T join if...

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

Locations

  • University of California - Irvine accepting new patients
    Irvine California 92691 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Verastem, Inc.
ID
NCT03372057
Phase
Phase 2
Study Type
Interventional
Last Updated