Trial Testing New Drug Treatments for Relapsed or Refractory Peripheral T-cell Lymphomas Including Phase 1 and Phase 2 Studies of Roginolisib, Golcadomide, and Azacitidine

What this Trial Is About

Researchers are evaluating new drugs or combinations of drugs to treat relapsed or refractory peripheral T-cell lymphomas through a platform trial consisting of multiple sub-studies. The study aims to collect exploratory data to better identify patient populations and inform the design of future clinical trials. Phase 1 sub-studies focus on determining safety and tolerability of increasing doses, while phase 2 sub-studies aim to find drugs that significantly improve patient outcomes. The trial includes at least two sub-studies Origina-ly-T, an open-label phase 2 study assessing the efficacy and safety of roginolisib, and GolcAza, an open-label phase 1 study identifying the maximum tolerated dose of golcadomide combined with oral 5-azacitidine. Participants receive the study treatments daily until unacceptable side effects, disease progression, or withdrawal. Origina-ly-T requires 31 patients, and GolcAza requires at least 18 patients. Participants will be monitored through clinical visits and assessments including progression-free survival and dose tolerance over a maximum two-year period. Researchers will evaluate safety, response rates, clinical benefit, time to next treatment or death, overall survival, and transplantation rates following treatment. The study requires adherence to visit schedules and protocol requirements, with careful safety monitoring throughout the treatment and follow-up phases.

A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas