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A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Trial Status: complete
This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral
dual inhibitor of phosphoinositide-3-kinase-delta, gamma (PI3K-δ,γ), in participants with
relapsed/refractory peripheral T-cell lymphoma (PTCL).
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:
Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following:
failed to achieve at least a PR after 2 or more cycles of standard therapy;
failed to achieve a CR after completion of standard therapy; and/or
persistent or progressive disease after an initial response
For participants with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
Measurable disease as defined by Lugano for PTCL, that is, at least 1 measurable disease lesion > 1.5 centimeters in at least one dimension by conventional techniques (fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography [CT], CT with contrast, magnetic imaging resonance)
Exclusion Criteria
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
Received prior allogeneic transplant
Received prior treatment with a 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
Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening
Known hypersensitivity to duvelisib and/or its excipients
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03372057.
