Status:
COMPLETED
A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Lead Sponsor:
SecuraBio
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 p...
Detailed Description
The study had 2 phases, a Dose Optimization Phase and an Expansion Phase. In the Dose Optimization Phase, participants were randomly assigned to 1 of 2 study cohorts, as follows: * Cohort 1: Duvelis...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03372057
Start Date
February 22 2018
End Date
December 22 2023
Last Update
March 7 2025
Active Locations (36)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of California - Irvine
Irvine, California, United States, 92691
3
University of California - Los Angeles
Los Angeles, California, United States, 90404
4
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322