About this trial
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).
Eligibility criteria
Qualifiers
Adult participants ≥18 years of age on the day of signing the informed consent form.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
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.
Disqualifiers
Participants who have T-cell lymphoma with active central nervous system involvement.
Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
History of primary immunodeficiency or sold organ transplantation.
History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.
Trial design
Treatments tested in this trial
- Soquelitinib
- Belinostat
- Pralatrexate