RecruitingPhase 3NCT06561048

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

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

Sponsor

Corvus Pharmaceuticals, Inc.

Enrollment

150 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

Lymphoma, T-Cell Peripheral T-Cell Lymphoma, Not Otherwise Specified Angioimmunoblastic T-cell Lymphoma Follicular T-Cell Lymphoma Nodal Peripheral T-Cell Lymphoma With TFH Phenotype Systemic Anaplastic Large Cell Lymphoma Lymphoma, T-Cell, Peripheral

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests soquelitinib — a new targeted oral drug — against standard chemotherapy options in adults with relapsed or treatment-resistant T-cell lymphoma (including peripheral T-cell lymphoma and anaplastic large-cell lymphoma) that has come back after prior treatment. **You may be eligible if...** - You are 18 or older with confirmed T-cell lymphoma that has relapsed or not responded to 1–3 prior treatment lines - Your lymphoma is visible on PET scan and measures at least 1.5 cm on CT scan - Your organ function is adequate and you are generally well enough to participate **You may NOT be eligible if...** - Your lymphoma has spread to the brain - You have HIV, active hepatitis B or C, or a primary immune deficiency - You have had a stem cell transplant from a donor - You have received a prior ITK inhibitor drug - You are pregnant or breastfeeding - You require immediate aggressive cancer-reducing therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSoquelitinib

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

DRUGBelinostat

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

DRUGPralatrexate

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06561048

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