Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo therapy aims to boost red blood cells in MDS patients

NCT ID NCT05181735

Disease control Sponsor: Groupe Francophone des Myelodysplasies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two drugs—luspatercept and erythropoietin (EPO)—for people with a low-risk form of myelodysplastic syndrome (MDS) that does not involve ring sideroblasts. Participants must have already tried EPO alone without success or be unable to take it. The goal is to find the best dose and see if the combination works better than luspatercept alone at improving blood counts. About 150 adults will take part in this early-phase trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients must meet all of the following criteria to participate in the study: * Myelodysplastic syndrome according to current WHO classification * Age ≥ 18 years * Patients with lower risk MDS according to IPSS classification (LOW, INT-1) without RS who failed to achieved a response or who subsequently relapse after ESA (at least 60000 U EPO-a over at least 12weeks or equivalent), without disease progression (or ineligible to ESA defined by EPO \> 500 UI/l) * Hemoglobin \< 9 gr/dl or Transfusion dependant (at least 3 RBCs in 16 wk in at least 2 transfusion episodes) * Non del(5q) syndrome * Adequat renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance ≥ 40 mL/min (MDRD formula). * Adequat liver function, defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal. * Patient is not known to be refractory to platelet transfusions. * Written informed consent. * Patient must understand and voluntarily sign consent form. * Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements. * ECOG performance status 0-2 at the time of screening. * A FCBP (female of childbearing potential) for this study was defined as a sexually mature woman who: (1) had not undergone a hysterectomy or bilateral oophorectomy; or (2) had not been naturally postmenopausal (amenorrhea following cancer therapy did not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). A FCBP participating in the study must: * Have had 2 negative pregnancy tests as verified by the investigator prior to starting IP (unless the screening pregnancy test was done within 72 hours of Cycle 1 Day 1). She must have had agreed to ongoing a monthly pregnancy testing during the course of the study and after EOT * If sexually active, agreed to have used, and been able to comply with, highly effective contraception\*\* without interruption, 5 weeks prior to starting IP, during treatment with IP (including dose interruptions), and for 12 weeks after discontinuation of IP. * \*\* Highly effective contraception was defined in this protocol as the following (information also appeared in the ICF): Hormonal contraception (eg, birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your tubes), or a partner with a vasectomy * Male subjects must: Have agreed to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (eg, polyurethane), during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions, and for at least 12 weeks following IP discontinuation, even if he had undergone a successful vasectomy Exclusion Criteria: A patient meeting any of the following criteria is not eligible to participate in the study: * Severe infection or any other uncontrolled severe condition. * Uncontrolled hypertension * Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months. * del(5q) syndrome * Use of investigational agents within 30 days or any anticancer therapy (including IMiD) within 2 weeks before the study entry with the exception of hydroxyurea. The patient must have recovered at least a grade 1 from all acute toxicity from any previous therapy. * Use of EPO within 4 weeks before the study entry * Active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma, or carcinoma in situ of the cervix or breast. * Patient already enrolled in another therapeutic trial of an investigational drug. * Known HIV infection or active hepatitis B or C. * Women who are or could become pregnant or who are currently breastfeeding. * Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form. * Patient eligible for allogeneic stem cell transplantation. * Known allergies to luspatercept or EPO or any of its excipients. * No affiliation to a health insurance system.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for MDS are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MDS Myelodysplastic syndromes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Careggi

    NOT_YET_RECRUITING

    Florence, 50134, Italy

  • CH Henri Duffaut d'Avignon

    RECRUITING

    Avignon, 84000, France

  • CH Le Mans

    RECRUITING

    Le Mans, 72037, France

  • CHR d'Orléans

    RECRUITING

    Orléans, 45067, France

  • CHRU Nancy - Hôpitaux de Brabois

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • CHRU de Lille - Hôpital Claude Huriez

    NOT_YET_RECRUITING

    Lille, 59037, France

  • CHRU de Limoges - Hôpital Dupuytren

    NOT_YET_RECRUITING

    Limoges, 87042, France

  • CHU Amiens-Picardie

    RECRUITING

    Amiens, 80054, France

  • CHU Angers

    RECRUITING

    Angers, 49933, France

  • CHU Nantes - Hôtel Dieu

    RECRUITING

    Nantes, 44093, France

  • CHU Saint Eloi

    RECRUITING

    Montpellier, 34295, France

  • CHU Toulouse - IUCT Oncopole

    RECRUITING

    Toulouse, 31059, France

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    RECRUITING

    Pessac, 33604, France

  • CHU de Grenoble

    RECRUITING

    Grenoble, 38043, France

  • CHU de Nice - Hôpital Archet 1

    RECRUITING

    Nice, 06202, France

  • CHU de Nîmes

    RECRUITING

    Nîmes, 30029, France

  • CHU de Poitiers

    RECRUITING

    Poitiers, 86021, France

  • CHU de Rennes - Hôpital Pontchaillou

    RECRUITING

    Rennes, 35033, France

  • CHU de Tours - Hôpital Bretonneau

    RECRUITING

    Tours, 37000, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, 76038, France

  • Centre Hospitalier Lyon Sud

    NOT_YET_RECRUITING

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Victor Dupouy

    RECRUITING

    Argenteuil, 95107, France

  • Centre Hospitalier de Cornouaille

    NOT_YET_RECRUITING

    Quimper, 29107, France

  • Centre Hospitalier de Mont de Marsan

    NOT_YET_RECRUITING

    Mont-de-Marsan, 40000, France

  • Centre Hospitalier de Périgueux

    RECRUITING

    Périgueux, 24019, France

  • Centre Hospitalier de Valence

    RECRUITING

    Valence, 26000, France

  • Centre Hospitalier de Versailles

    NOT_YET_RECRUITING

    Le Chesnay, 78150, France

  • Centre Hospitalier de la Côte Basque

    NOT_YET_RECRUITING

    Bayonne, 64109, France

  • Clinique de l'Europe

    NOT_YET_RECRUITING

    Amiens, 80090, France

  • Hôpital Avicenne

    RECRUITING

    Bobigny, 93009, France

  • Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Cochin

    NOT_YET_RECRUITING

    Paris, 75014, France

  • Hôpital NOVO

    NOT_YET_RECRUITING

    Pontoise, 95300, France

  • Hôpital Necker

    RECRUITING

    Paris, 75015, France

  • Hôpital Privé Sévigné

    RECRUITING

    Cesson-Sévigné, 35510, France

  • Hôpital Saint Louis

    RECRUITING

    Paris, 75010, France

  • Hôpital privé du Confluent

    RECRUITING

    Nantes, 44277, France

  • IRCCS

    RECRUITING

    Candiolo, 10060, Italy

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

    RECRUITING

    Saint-Priest-en-Jarez, 42271, France

  • Strasbourg Oncologie Libérale Clinique Sainte Anne

    RECRUITING

    Strasbourg, 67000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.