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

About

Brief 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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
18-001586
Category
Hematology-Oncology
Oncology
Contact
Shenetra Walker
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT03372057
For detailed technical eligibility, visit ClinicalTrials.gov.