Phase 1 Study of Ruxolitinib and Duvelisib for Adults with Relapsed or Refractory T-Cell and NK-Cell Lymphomas Including T-PLL and TFH Lymphoma Expansion Cohorts

What this Trial Is About

Researchers are evaluating the safety of the combination of ruxolitinib and duvelisib in people with relapsed or refractory NK-cell or T-cell lymphomas, including specific types like T-cell prolymphocytic leukemia and T-follicular helper lymphoma. The study is a Phase I trial designed to find out the effects of these drugs given at fixed and varying doses. It has three parts dose escalation, dose expansion, and a cohort expansion for certain lymphoma subtypes. Participants will receive ruxolitinib 20mg twice daily combined with duvelisib at doses of 25mg, 50mg, or 75mg twice daily taken by mouth every 12 hours. The study uses a dose-escalation design to evaluate different doses of duvelisib alongside a fixed dose of ruxolitinib. Adjustments to doses can be made if deemed clinically favorable. The trial also includes an expansion phase for patients with specific lymphoma types to further evaluate treatment effects. During the study, participants will be monitored for safety and disease control at defined intervals, including assessments over one year to determine the optimal dose. Researchers will measure disease control rates at six months and monitor laboratory tests and clinical status. The study involves regular evaluations to track treatment effects and safety, with participation lasting according to the study schedule and treatment phases.

A Study of Ruxolitinib and Duvelisib in People With Lymphoma