Phase 3 Trial Comparing Duvelisib to Gemcitabine or Bendamustine for Adults With Relapsed or Refractory Nodal T Cell Lymphoma With T Follicular Helper Phenotype

What this Trial Is About

Researchers are evaluating the progression-free survival benefit of duvelisib monotherapy compared to the investigators choice of gemcitabine or bendamustine in adults with relapsed or refractory nodal T cell lymphoma that has a T follicular helper TFH phenotype. This study is a phase 3, open-label, randomized controlled trial focusing on this specific type of lymphoma after prior treatments have failed. Participants will be randomly assigned to receive either duvelisib or one of two chemotherapy regimens chosen by the investigator before randomization. Duvelisib is given as oral capsules twice daily in 28-day cycles. The chemotherapy options include gemcitabine administered intravenously on days 1, 8, and 15 of a 28-day cycle for up to six cycles, or bendamustine given intravenously on days 1 and 2 of a 21-day cycle for up to six cycles. During the study, participants will be closely monitored for progression-free survival as assessed by an independent review committee for up to three years. Other outcomes include overall survival, response rates, duration of response, and quality of life measures. Blood samples will be taken to measure duvelisib and its metabolites at specified times. Safety evaluations and assessments of adverse events will also be conducted throughout the study period.

A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype