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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SecuraBio

Criteria

Inclusion Criteria:

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:

1. Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS);

2. Angioimmunoblastic T-cell lymphomas (AITL);

3. Anaplastic large cell lymphoma (ALCL); or

4. Natural-killer/T-cell lymphoma (NKTL)

3. Received at least 2 cycles of one prior regimen administered with curative intent and one of the following:

1. failed to achieve at least a partial response after 2 or more cycles;

2. failed to achieve a complete response after 6 or more cycles; and/or

3. progressed after an initial response

4. For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin

5. 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:

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