A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Completed · Phase 2
Conditions studied: Peripheral T-cell Lymphoma
In brief
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).
Key facts
- Study ID
- NCT03372057
- Run by
- SecuraBio
- People needed
- 156
- Starts
- 2018-02-22
- Expected to finish
- 2023-12-22
- Last updated by the study team
- 2025-03-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- Angioimmunoblastic T-cell lymphomas;
- Anaplastic large cell lymphoma (ALCL); or
- Natural-killer/T-cell lymphoma
- 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)
You may not qualify if…
- 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
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- University of California - Irvine — Irvine, California, United States
- University of California - Los Angeles — Los Angeles, California, United States
- Emory University Winship Cancer Institute — Atlanta, Georgia, United States
- Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- University of Maryland — Baltimore, Maryland, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Washington University — St Louis, Missouri, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Stony Brook Cancer Center — Stony Brook, New York, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Novant Health — Charlotte, North Carolina, United States
- Duke University — Durham, North Carolina, United States
- The Ohio State University — Columbia, Ohio, United States
- Toledo Cancer Center — Toledo, Ohio, United States
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
- Baylor Research Institute - Charles Sammons Cancer Center — Dallas, Texas, United States
- Universitätsklinikum Carl Gustav Carus — Dresden, Saxony, Germany
- Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV — Halle, Saxony-Anhalt, Germany
- ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo — Bergamo, Italy
- A.O.di Bologna Policl.S.Orsola — Bologna, Italy
- Ieo, Irccs — Milan, Italy
- Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore — Roma, Italy
Full record on ClinicalTrials.gov
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