Study of JAK1 Inhibitor Golidocitnib for Treating Relapsed or Resistant Indolent TNK-Cell Lymphomas

What this Trial Is About

Indolent TNK-cell lymphomas are a group of slow-growing lymphoproliferative diseases originating from T and NK cells, which currently have no cure. For patients whose disease does not respond to initial treatments, options are limited and outcomes are poor. This Phase 2 clinical trial aims to explore the feasibility, effectiveness, and safety of using the JAK1 inhibitor Golidocitnib to treat relapsed or refractory indolent TNK-cell lymphomas. In this open-label study, 48 patients will receive oral Golidocitnib at a dose of 150 mg once daily in 28-day cycles. Treatment will continue for up to 24 cycles or until disease progression, lack of response within the first 6 cycles, or intolerable side effects occur. Effectiveness will be assessed every cycle during the first year and every two cycles thereafter. Participants will undergo regular evaluations including assessments of response to treatment and monitoring for safety throughout the study, which may last up to 5 years for outcome measures. Key outcomes include overall response rate, complete remission rate, duration of remission, progression-free survival, and overall survival. The study also includes monitoring of side effects and disease control over time to evaluate the impact of Golidocitnib in this patient population.

JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas