A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients with Relapsed or Refractory Periperal T-cell Lymphoma (PTCL)

Protocol # :
Peripheral T-cell Lymphoma
Disease Sites
Non-Hodgkin's Lymphoma
Principal Investigator
Jacobsen, Eric
Site Research Nurses
Brennan, Lisa
Coleman, Kimberly, C.
Guy-Hamilton, Rebecca
Kilcommons, Marykate
McDermott, Kathleen
Normilus, Samantha
Patterson, Victoria

Trial Description

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/refractory Peripheral T-cell Lymphoma

Eligibility Requirements

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 standard regimen for newly diagnosed advanced PTCL,
and one of the following:

1. failed to achieve at least a PR after 2 or more cycles of standard therapy;

2. failed to achieve a CR after completion of standard therapy; and/or

3. persistent or progressive disease after an initial response

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

5. Measurable disease as defined by Lugano for PTCL, that is, at least 1 measurable
disease lesion > 1.5 cm in at least one dimension by conventional techniques
(18FDG-PET-CT, CT with contrast, MRI)

Exclusion Criteria:

1. Primary leukemic PTCL subtypes (that is, T-cell prolymphocytic leukemia, T-cell large
granular lymphocytic leukemia, adult T-cell leukemia/lymphoma and aggressive NK-cell
leukemia) or transformed mycosis fungoides

2. Received prior allogeneic transplant

3. Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor

4. Known central nervous system involvement by PTCL

5. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic
steroids > 20 mg of prednisone (or equivalent) once daily (QD)

6. Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening

7. Known hypersensitivity to duvelisib and/or its excipients