RecruitingPhase 1Phase 2NCT07018752

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

Sponsor

The Lymphoma Academic Research Organisation

Enrollment

49 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

Peripheral T Cells Lymphoma (PTCL)

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a platform trial testing new drug combinations in patients with a rare type of blood cancer called peripheral T-cell lymphoma (PTCL) that has come back or stopped responding to treatment. **You may be eligible if...** - You are 18 or older - You have been confirmed to have PTCL (by tissue biopsy) that has relapsed or stopped responding to prior treatment - You are well enough to be up and about most of the day (ECOG 0–2, or 3 in limited cases) - You have had at least one prior treatment for this cancer **You may NOT be eligible if...** - You have mycosis fungoides, Sézary syndrome, lymphoblastic lymphoma, or large granular lymphocytic lymphoma - You have active uncontrolled infections or severe heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active or uncontrolled brain involvement from your cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGroginolisib

Roginolisib daily intake

DRUGgolcadomide

Golcadomide daily intake

DRUGazacitidine

oral 5-azacitidine daily intake

Locations(20)

Institut d'Hématologie de Basse Normandie - Service Hématologie (CHU Hôpital Côte de Nacre)

Caen, France

CHU Estaing - Service Thérapie Cellulaire et Hématologie Clinique

Clermont-Ferrand, France

Hôpital Henri Mondor - Unité Hémopathies Lymphoïdes

Créteil, France

CHU Dijon Bourgogne - Service Hématologie Clinique

Dijon, France

CHU de Grenoble - Service Hématologie

La Tronche, France

CH du Mans - Centre de Cancérologie de la Sarthe - Service Hématologie

Le Mans, France

CHU de Lille - Hôpital Claude Huriez - Service des Maladies du Sang

Lille, France

Institut Paoli Calmettes - Service Hématologie

Marseille, France

CHU de Montpellier - Département d'Hématologie Clinique

Montpellier, France

CHU de Nantes - Service Hématologie

Nantes, France

Hôpital Necker - Service Hématologie Adultes

Paris, France

CHU de Bordeaux - Hôpital Haut-Lévêque - Centre François Magendie - Service d'Hématologie et Thérapie Cellulaire

Pessac, France

CHU Lyon-Sud - Hématologie Clinique

Pierre-Bénite, France

CHU de Poitiers - Hôpital de la Milétrie - Service d'Oncologie Hématologique et Thérapie Cellulaire

Poitiers, France

CHU Pontchaillou - Hématologie Clinique

Rennes, France

Centre Henri Becquerel - Service Hématologie

Rouen, France

Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie

Saint-Etienne, France

CH de la Côte Basque - Service Hématologie

Saint-Jean-de-Luz, France

Institut de Cancérologie Strasbourg Europe - Service Hématologie

Strasbourg, France

CHRU Nancy - Hôpital Brabois - Service Hématologie

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07018752

Related Trials

Zeprumetostat, Azacitidine Combined With Lipo-MIT in R/R PTCL

NCT073723521 location

Polyspecific Antibodies in Lymphoproliferative T-cell Disorders

NCT064957238 locations