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

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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