A Study of Duvelisib in Patients 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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225029

Enrollment

120

Registered

2020-01-21

Start date

2020-03-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral T-cell Lymphoma

Interventions

investigational material(s) Generic name etc : IPI-145 INN of investigational material : Duvelisib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Pathologically-confirmed PTCL, as defined by the World Health Organization. Slides must be submitted for central pathology review. Results of central pathology review are not required prior to initiation of treatment. -Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following: (a) failed to achieve at least a partial response after 2 or more cycles of standard therapy; (b) failed to achieve a complete response after completion of standard therapy; and/or (c) persistent or progressive disease after an initial response -For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin -Measurable disease as defined by Lugano for PTCL, i.e., at least 1 measurable disease lesion > 1.5 cm in at least one dimension by conventional techniques (18FDG-PET-CT, CT with contrast, MRI)

Exclusion criteria

Exclusion criteria: -Primary leukemic PTCL subtypes (i.e., 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 treatment with a phosphoinositide-3-kinase (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 (QD) -Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening

Design outcomes

Primary

Measure	Time frame
efficacy -ORR	—

Secondary

Measure	Time frame
safety efficacy -DOR -Safety parameters -PFS -DCR -OS -PK parameters	—

Countries

Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026