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).
Official Title
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
Details
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.
Keywords
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, Lymphoma, T-Cell, Peripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL-NOS), Follicular Helper T-Cell Lymphoma (FHTCL), Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-Cell Lymphoma (FTCL), Nodal Peripheral T-Cell Lymphoma with T Follicular Helper Phenotype (PTCL-Tfh), Systemic Anaplastic Large Cell Lymphoma (sALCL), T-Cell Lymphoma, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic, belinostat, 10-propargyl-10-deazaaminopterin, Soquelitinib, Pralatrexate