Phase 2
Completed N=33
A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Source: ClinicalTrials.gov NCT03372057 ↗Enrolled (actual)
33
Serious AEs
53.2%
Results posted
Feb 2025
Primary outcomePrimary: Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria — 53.8; 53.8 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria |
53.8; 53.8 | — |
| PRIMARY ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria |
48.0 | — |
| SECONDARY Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria |
4.22; 3.32 | — |
| SECONDARY Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria |
3.55; 3.55 | — |
| SECONDARY Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria |
61.5; 61.5 | — |
| SECONDARY DOR as Assessed by the IRC Using the Lugano Criteria |
7.9 | — |
| SECONDARY PFS as Assessed by the IRC Using the Lugano Criteria |
3.4 | — |
| SECONDARY DCR as Assessed by the IRC Using the Lugano Criteria |
49.6 | — |
| SECONDARY Overall Survival (OS) |
6.70; 10.58; 12.4 | — |
| SECONDARY Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite) |
1238.1; 2070.0; 2873.7; 1492.5; 2648.2; 1310.4 | — |
Eligibility Criteria
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;
- 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
Data sourced from ClinicalTrials.gov (NCT03372057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.