CompletedPhase 2

A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

United States156 participantsStarted 2018-02-22

Plain-language 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 peripheral T-cell lymphoma (PTCL).

Who can participate

Age range18 Years

SexALL

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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:
✓. 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;

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

What they're measuring

Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria

Timeframe: 56 days (2 cycles; 28-day cycles)

ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria

Timeframe: 56 days (2 cycles; 28-day cycles)

Trial details

NCT IDNCT03372057

SponsorSecuraBio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-22

Results submitted2024-12-19

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