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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Soquelitinib 200 mg tablets will be taken by mouth two times a day
Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle
Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle
City of Hope National Medical Center
Duarte, California, United States
RECRUITINGUniversity of California, Irvine
Irvine, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGYale University
New Haven, Connecticut, United States
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
Objective response rate
The rate of participants who achieve a partial response or complete response as assessed by the Independent Review Committee according to the Revised Criteria for Response Assessment of Malignant Lymphoma (Lugano Classification 2014), and modified Severity Weighted Assessment Tool (mSWAT) for participants with skin involvement
Time frame: Up to 2 years post study treatment initiation
Overall survival
Time from first study treatment to death from any cause
Time frame: Up to 4 years post study treatment initiation
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Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine
Miami, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGNorth Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC
Chicago, Illinois, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGUniversity of Maryland Medical Center
Baltimore, Maryland, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITING...and 24 more locations