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

Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:February 22, 2018
End Date:December 2021
Contact:Jasminder Soto

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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)

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

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.

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

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
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