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RECRUITING
NCT06561048
PHASE3

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Sponsor: Corvus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

Official title: A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-10-02

Completion Date

2028-12

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Soquelitinib

Soquelitinib 200 mg tablets will be taken by mouth two times a day

DRUG

Belinostat

Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle

DRUG

Pralatrexate

Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle

Locations (34)

City of Hope National Medical Center

Duarte, California, United States

University of California, Irvine

Irvine, California, United States

University of California San Francisco

San Francisco, California, United States

Yale University

New Haven, Connecticut, United States

Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Roger Cancer Center University of Michigan Health

Ann Arbor, Michigan, United States

Washington University in St. Louis

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

North Carolina Cancer Hospital

Chapel Hill, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Washington Fred Hutch Cancer Center

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

ICON Cancer Centre

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Center

Bedford Park, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Epworth Healthcare

Richmond, Victoria, Australia

Linear Clinical Research

Perth, Western Australia, Australia

BC Cancer Research Institute

Vancouver, British Columbia, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

The Princess Margaret Cancer Centre

Toronto, Ontario, Canada