NCT07018752

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

A Platform Trial, Evaluating New Drugs or Combination in Relapsed or Refractory Peripheral T-cell Lymphomas

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a platform trial for the evaluation of new drugs or combination of drugs in relapsed or refractory peripheral T-cell lymphomas. The objective of the study is to generate exploratory data on new drugs or combination of drugs to treat refractory/relapse peripheral T-cells lymphoma to better identify the population of interest and design future correct clinical trials. Primary objectives of the different sub-studies : * phase 1 sub-studies: determine the safety and tolerability of escalating doses of the sub-study treatment * phase 2 sub-studies: identify drugs that will improve significantly the outcome in target patients Secondary objectives of both sub-studies: analyze the response rate, the clinical benefit rate, the progression-free survival, the duration of response, the time to next treatment or death, the overall survival, the rate of transplantation following study treatment and the safety profile of the drugs used

Detailed description

This study is a platform trial evaluating new drugs or combination of drugs in relapsed or refractory peripheral T-cell lymphomas via multiple sub-studies. For phase 1 sub-studies, at least 18 evaluable patients are required per each sub-study. For phase 2 sub-studies, 31 evaluable patients are required per sub-study. Each sub-study has its own specificities: * Origina-ly-T: open-label phase 2 study evaluating the efficacy and safety of roginolisib in relapsed/refractory peripheral T-cells lymphoma. Study treatment will be administered until unacceptable toxicity, disease progression, subject/physician decision to withdraw, whichever happens first. * GolcAza: open-label phase 1 study to identify the maximum tolerated dose of golcadomide in association with oral 5-azacitidine and evaluate the efficacy and safety of the determined combination of oral 5-azacitidine and golcadomide in relapsed/refractory follicular helper T-cell lymphoma subjects. Subjects will receive golcadomide and oral 5-azacitidine until end of study or until disease progression, unacceptable toxicity, subject/physician decision to withdraw, whichever occurs first.

Conditions

• Peripheral T Cells Lymphoma (PTCL)

Interventions

Type	Name	Description
DRUG	roginolisib	Roginolisib daily intake
DRUG	golcadomide	Golcadomide daily intake
DRUG	azacitidine	oral 5-azacitidine daily intake

Timeline

• Start date: 2025-08-20
• Primary completion: 2028-04-01
• Completion: 2030-01-01
• First posted: 2025-06-12
• Last updated: 2026-02-11

Locations

20 sites across 1 country: France