Clinical Trials

Trial Description:
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.

Eligibility Requirements:
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

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