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

NCT03372057 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: VS-0145-2252019-001123-13
• Study Type: interventional
• Target: 156
• Locations: 5 countries
• Sites: 36

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).

Conditions

Peripheral T-cell Lymphoma

Keywords

Lymphoma; T-cell Lymphoma; Relapse; Refractory; PI3K-δ,γ

Outcome Measures

Primary Outcomes (2)

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

  ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.

  56 days (2 cycles; 28-day cycles)

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

  ORR was defined as the percentage of participants with CR + PR, as assessed by the IRC using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.

  56 days (2 cycles; 28-day cycles)

Secondary Outcomes (8)

• Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria

  Up to 70 months

• Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria

  Up to 70 months

• Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria

  Up to 8 weeks

• DOR as Assessed by the IRC Using the Lugano Criteria

  Up to 70 months

• PFS as Assessed by the IRC Using the Lugano Criteria

  Up to 70 months

Study Arms (3)

Dose Optimization Phase: Cohort 1

EXPERIMENTAL

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.

Drug: Duvelisib

Dose Optimization Phase: Cohort 2

EXPERIMENTAL

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

Drug: Duvelisib

Expansion Phase

EXPERIMENTAL

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).

Drug: Duvelisib

Interventions

Duvelisib DRUG

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

Also known as: IPI-145

Dose Optimization Phase: Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (36)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California - Irvine

Irvine, California, 92691, United States

Location

University of California - Los Angeles

Los Angeles, California, 90404, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

University of Maryland

Baltimore, Maryland, 20742, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Novant Health

Charlotte, North Carolina, 28204, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

The Ohio State University

Columbia, Ohio, 43202, United States

Location

Toledo Cancer Center

Toledo, Ohio, 43623, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Baylor Research Institute - Charles Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

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

Halle, Saxony-Anhalt, 06120, Germany

Location

ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo

Bergamo, 24127, Italy

Location

A.O.di Bologna Policl.S.Orsola

Bologna, 40138, Italy

Location

Ieo, Irccs

Milan, 20141, Italy

Location

Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

Azienda Ospedaliera Santa Maria di Terni

Terni, 05100, Italy

Location

Japanese Site 8

Fukuoka, Japan

Location

Japanese Site 5

Kobe, Japan

Location

Japanese Site 3

Miyagi, Japan

Location

Japanese Site 6

Nagoya, Japan

Location

Japanese Site 7

Niigata, Japan

Location

Japanese Site 1

Okayama, Japan

Location

Japanese Site 2

Tokyo, Japan

Location

Japanese Site 4

Tokyo, Japan

Location

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma; Lymphoma, T-Cell; Recurrence

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ohad Bentur, MD, MHA, MSc
• Organization: Secura Bio, Inc.

obentur@securabio.com

1-702-254-0011

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 13, 2017
• Study Start: February 22, 2018
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: March 7, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-03

Locations

US (19); JP (8); GB (2); DE (2); IT (5)