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

NCT ID: NCT03372057

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2023-12-22

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 peripheral T-cell lymphoma (PTCL).

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: Duvelisib per oral (PO) twice daily (BID) at a starting dose of 25 milligrams (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.
• Cohort 2: Duvelisib 75 mg PO BID, administered in 28-day cycles.

A total of 20 participants were to be enrolled in the Dose Optimization Phase, with 10 participants per cohort. Based on the safety and activity data obtained in the Dose Optimization Phase of the study, the Expansion Phase dose of duvelisib was to be determined.

In the Expansion Phase, approximately 100-130 participants were to be enrolled and receive duvelisib dose in 28-day cycles as determined in Dose Optimization Phase.

Conditions

Peripheral T-cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Optimization Phase: Cohort 1

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.

Group Type: EXPERIMENTAL

Duvelisib

Intervention Type: DRUG

Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.

Dose Optimization Phase: Cohort 2

Duvelisib 75 mg PO BID, administered in 28-day cycles.

Group Type: EXPERIMENTAL

Duvelisib

Intervention Type: DRUG

Duvelisib PO 75 mg BID in 28-day cycles.

Expansion Phase

Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with complete response (CR), partial response (PR) or stable disease (SD), in 28-day cycles (dose determined in Optimization Phase).

Group Type: EXPERIMENTAL

Duvelisib

Intervention Type: DRUG

Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase).

Interventions

Duvelisib

Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.

Intervention Type: DRUG

Duvelisib

Duvelisib PO 75 mg BID in 28-day cycles.

Intervention Type: DRUG

Duvelisib

Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase).

Intervention Type: DRUG

Other Intervention Names

IPI-145; IPI-145; IPI-145

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SecuraBio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

City of Hope National Medical Center

Duarte, California, United States

University of California - Irvine

Irvine, California, United States

University of California - Los Angeles

Los Angeles, California, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Stony Brook Cancer Center

Stony Brook, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Novant Health

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

The Ohio State University

Columbia, Ohio, United States

Toledo Cancer Center

Toledo, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Baylor Research Institute - Charles Sammons Cancer Center

Dallas, Texas, United States

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV

Halle, Saxony-Anhalt, Germany

ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo

Bergamo, , Italy

A.O.di Bologna Policl.S.Orsola

Bologna, , Italy

Ieo, Irccs

Milan, , Italy

Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore

Roma, , Italy

Azienda Ospedaliera Santa Maria di Terni

Terni, , Italy

Japanese Site 8

Fukuoka, , Japan

Japanese Site 5

Kobe, , Japan

Japanese Site 3

Miyagi, , Japan

Japanese Site 6

Nagoya, , Japan

Japanese Site 7

Niigata, , Japan

Japanese Site 1

Okayama, , Japan

Japanese Site 2

Tokyo, , Japan

Japanese Site 4

Tokyo, , Japan

Christie Hospital NHS Foundation Trust

Manchester, , United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Countries

United States; Germany; Italy; Japan; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-001123-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VS-0145-225

Identifier Type: -

Identifier Source: org_study_id