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
Start Date
10/2/2024
Completion Date
12/1/2028
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).
Detailed Description
This is a Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib, an oral interleukin-2-inducible T cell kinase (ITK) inhibitor, versus physician's choice standard of care (SOC) treatment of either belinostat or pralatrexate 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). Approximately 150 participants will be randomized at a 1:1 ratio to the 2 treatment arms (soquelitinib or SOC) and will be stratified by region of the world, age, and time to relapse for the most recent prior therapy. Participants will receive study treatment for up to a maximum of 2 years, unacceptable toxicity, or disease progression, whichever is earlier. Participants randomized to receive SOC who have confirmation of progressive disease may have the opportunity to crossover to receive treatment with soquelitinib.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Soquelitinib
Belinostat
Pralatrexate
Conditions
Locations
City of Hope National Medical Center
Duarte, California 91010
United States
University of California, Irvine
Irvine, California 92697
United States
University of California San Francisco
San Francisco, California 94143
United States
Yale University
New Haven, Connecticut 06520
United States
Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine
Miami, Florida 33136
United States
Emory University
Atlanta, Georgia 30322
United States
North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC
Chicago, Illinois 60611
United States
University of Iowa
Iowa City, Iowa 52242
United States
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Roger Cancer Center University of Michigan Health
Ann Arbor, Michigan 48109
United States
Washington University in St. Louis
St Louis, Missouri 63130
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Weill Cornell Medicine
New York, New York 10065
United States
North Carolina Cancer Hospital
Chapel Hill, North Carolina 27514
United States
The Ohio State University
Columbus, Ohio 43210
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Washington Fred Hutch Cancer Center
Seattle, Washington 98109
United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
Australia
St George Hospital
Kogarah, New South Wales 2217
Australia
ICON Cancer Centre
South Brisbane, Queensland 4101
Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
Flinders Medical Center
Bedford Park, South Australia 5042
Australia
Royal Hobart Hospital
Hobart, Tasmania 7000
Australia
Box Hill Hospital
Box Hill, Victoria 3128
Australia
Austin Hospital
Heidelberg, Victoria 3084
Australia
Epworth Healthcare
Richmond, Victoria 3121
Australia
Linear Clinical Research
Perth, Western Australia 6009
Australia
BC Cancer Research Institute
Vancouver, British Columbia V5Z4E6
Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario K1H8L6
Canada
The Princess Margaret Cancer Centre
Toronto, Ontario M5G2C4
Canada