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
Corvus Pharmaceuticals, Inc.
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).
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult participants ≥18 years of age on the day of signing the informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms. 4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies. 5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomograph…
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 CenterDuarte, California
- University of California, IrvineIrvine, California
- University of California San FranciscoSan Francisco, California
- Yale UniversityNew Haven, Connecticut
- Sylvester Comprehensive Cancer Center University of Miami Miller School of MedicineMiami, Florida
- Emory UniversityAtlanta, Georgia