A Phase 2 Study to Investigate the Safety, Tolerability and Anti-tumor Activity of Golidocitinib in Combination With CHOP as the Front-line Treatment for Participants With Peripheral T-cell Lymphomas (PTCL)
This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in Combination with CHOP as the front-line Treatment for Participants with Peripheral T-cell Lymphomas (PTCL).
• Participants must sign an informed consent form prior to trial-specific procedures, sampling, and analysis.
• Participants must be at least 18 years of age (inclusive) at the time of signing the informed consent form.
• The participant has an ECOG performance status of 0 to 2 and has not deteriorated in the past 2 weeks.
• Life expectancy ≥ 3 months.
• Histologically confirmed diagnosis of PTCL and no prior systemic anti-lymphoma therapy; and assessed by a local pathologist according to the 2016 revised World Health Organization Classification of Lymphoid Tumors (Swerdlow SH et al., 2017) as the following subtypes:
‣ peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS)
⁃ angioimmunoblastic T cell lymphoma (AITL)
⁃ follicular T-cell lymphoma (FTCL)
⁃ nodular PTCL with follicular helper T-cell phenotype (nodular PTCL with TFH phenotype)
⁃ ALK- anaplastic large cell lymphoma (ALK- ALCL)
⁃ enteropathy-associated T-cell lymphoma (EATL)
⁃ monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)
⁃ hepatosplenic T-cell lymphoma (HSTCL)
⁃ subcutaneous panniculitis-like T-cell lymphoma (SPTCL)
• Adequate bone marrow reserve and organ system function reserve
• Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by ECHO.
• Participants should be able and willing to comply with the study protocol requirement.
• Adequate birth control measures should be taken during study treatment and the corresponding washout period.