Clinical trial · Interventional
A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duvelisib | Drug | Duvelisib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Optimization Phase: Cohort 1
- description
- Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
- interventionNames
- Drug: Duvelisib
- type
- EXPERIMENTAL
- label
- Dose Optimization Phase: Cohort 2
- description
- Duvelisib 75 mg PO BID, administered in 28-day cycles.
- interventionNames
- Drug: Duvelisib
- type
- EXPERIMENTAL
- label
- Expansion Phase
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years of age 2. Diagnosis of one of the following histologic subtypes of PTCL, pathologically confirmed, as defined by the World Health Organization: 1. Peripheral T-cell lymphoma-not otherwise specified; 2. Angioimmunoblastic T-cell lymphomas; 3. Anaplastic large cell lymphoma (ALCL); or 4. Natural-killer/T-cell lymphoma 3. Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following: 1. failed to achieve at least a PR after 2 or more cycles of standard therapy; 2. failed to achieve a CR after completion of standard therapy; and/or 3. persistent or progressive disease after an initial response 4. For participants with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin 5. 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: 1. 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 2. Received prior allogeneic transplant 3. Received prior treatment with a PI3K inhibitor 4. Known central nervous system involvement by PTCL 5. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids \> 20 mg of prednisone (or equivalent) once daily 6. Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening 7. Known hypersensitivity to duvelisib and/or its excipients
References
Publications (1)
- DERIVEDMehta-Shah N, Zinzani PL, Jacobsen ED, Zain J, Mead M, Casulo C, Gritti G, Pinter-Brown L, Izutsu K, Sidransky D, Bentur OS, Pro B, Fox CP, Brammer JE, Horwitz SM. Duvelisib Induces Deep Responses in Peripheral T-Cell Lymphoma: Final Results of the Phase II PRIMO Trial of Duvelisib in Relapsed/Refractory Peripheral T-Cell Lymphoma. J Clin Oncol. 2026 Jul 10;44(20):1889-1898. doi: 10.1200/JCO-25-03120. Epub 2026 Apr 22. PMID 42018969