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
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.
Arms & 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
Outcome measures
Primary
Progression-free survival
Time from first study treatment to first occurrence of progression (as assessed by the Independent Review Committee) or death, whichever occurs first
Time frame: Up to 4 years post study treatment initiation
Secondary
Objective response rate
Time frame: Up to 2 years post study treatment initiation
Overall survival
Time frame: Up to 4 years post study treatment initiation
Eligibility criteria
Study locations (21)
City of Hope National Medical Center
Duarte, California, 91010
University of California, Irvine
Irvine, California, 92697
University of California San Francisco
San Francisco, California, 94143
Yale University
New Haven, Connecticut, 06520
Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine
Miami, Florida, 33136
Emory University
Atlanta, Georgia, 30322
North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC
Chicago, Illinois, 60611
University of Iowa
Iowa City, Iowa, 52242
University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roger Cancer Center University of Michigan Health
Ann Arbor, Michigan, 48109
Washington University in St. Louis
St Louis, Missouri, 63130
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medicine
New York, New York, 10065
North Carolina Cancer Hospital
Chapel Hill, North Carolina, 27514
The Ohio State University
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030
University of Washington Fred Hutch Cancer Center
Seattle, Washington, 98109
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792