RecruitingPhase 1Phase 2NCT05181735

Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA

A Randomized Phase I/ II Multicenter Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA


Sponsor

Groupe Francophone des Myelodysplasies

Enrollment

150 participants

Start Date

May 18, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Eprex and a drug called Luspatercept Injection [Reblozyl] for people with mds and myelodysplastic syndromes. The study is currently recruiting participants at 40 locations. People eligible for this study include aged 18 Years and older.

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.

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Interventions

DRUGLuspatercept Injection [Reblozyl]

All patients will receive Luspatercept subcutaneously on day 1 of each 21 day cycle (every 3 weeks) at the selected dose according to part A : 1.75mg/kg or 1.33 mg/kg or 0.8 mg/kg

DRUGEprex

Epoietin alfa will be adminstered as a subcutaneous injection at the selected dose according to part A : 30 000 UI/week or 60 000 UI/week, every week


Locations(40)

CHU Amiens-Picardie

Amiens, France

Clinique de l'Europe

Amiens, France

CHU Angers

Angers, France

Centre Hospitalier Victor Dupouy

Argenteuil, France

CH Henri Duffaut d'Avignon

Avignon, France

Centre Hospitalier de la Côte Basque

Bayonne, France

Hôpital Avicenne

Bobigny, France

Hôpital Privé Sévigné

Cesson-Sévigné, France

CHU de Grenoble

Grenoble, France

Centre Hospitalier de Versailles

Le Chesnay, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

CH Le Mans

Le Mans, France

CHRU de Lille - Hôpital Claude Huriez

Lille, France

CHRU de Limoges - Hôpital Dupuytren

Limoges, France

Centre Hospitalier de Mont de Marsan

Mont-de-Marsan, France

CHU Saint Eloi

Montpellier, France

CHU Nantes - Hôtel Dieu

Nantes, France

Hôpital privé du Confluent

Nantes, France

CHU de Nice - Hôpital Archet 1

Nice, France

CHU de Nîmes

Nîmes, France

CHR d'Orléans

Orléans, France

Hôpital Saint Louis

Paris, France

Hôpital Cochin

Paris, France

Hôpital Necker

Paris, France

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, France

Centre Hospitalier de Périgueux

Périgueux, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CHU de Poitiers

Poitiers, France

Hôpital NOVO

Pontoise, France

Centre Hospitalier de Cornouaille

Quimper, France

CHU de Rennes - Hôpital Pontchaillou

Rennes, France

Centre Henri Becquerel

Rouen, France

Institut de Cancérologie et d'Hématologie Universitaire de Saint-Etienne

Saint-Priest-en-Jarez, France

Strasbourg Oncologie Libérale Clinique Sainte Anne

Strasbourg, France

CHU Toulouse - IUCT Oncopole

Toulouse, France

CHU de Tours - Hôpital Bretonneau

Tours, France

Centre Hospitalier de Valence

Valence, France

CHRU Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, France

IRCCS

Candiolo, Italy

AOU Careggi

Florence, Italy

View Full Details on ClinicalTrials.gov

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NCT05181735


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