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Clinical Trials in France / NCT06045689
Active, not recruiting Phase 3

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

NCT06045689 · tracked via the Priya Life Science France tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2023-10-05
Last updated
2026-06-15

Condition(s) studied

Myelodysplastic Syndromes

Investigational drug(s) / intervention(s)

Luspatercept →

Luspatercept: Specified dose on specified days.

Study summary

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease. * Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. * Participant must have red blood cell transfusions according to study criteria. Exclusion Criteria: * Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. * Participant has had a prior allogeneic or autologous stem cell transplant. * Participant has known history or diagnosis of AML. * Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply

Primary outcome measure(s)

  • Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24 — Up to week 24

Trial sites (52)

FacilityCityRegionStatus
Local Institution - 0051 Los Alamitos California
Local Institution - 0033 New Haven Connecticut
Local Institution - 0055 St. Petersburg Florida
Local Institution - 0056 Wellington Florida
Local Institution - 0020 Kansas City Kansas
Local Institution - 0025 Paducah Kentucky
Local Institution - 0011 Detroit Michigan
Local Institution - 0059 St Louis Missouri
Local Institution - 0058 Morristown New Jersey
Local Institution - 0032 New York New York
Local Institution - 0054 Eugene Oregon
Local Institution - 0036 Pittsburgh Pennsylvania
Local Institution - 0043 Amarillo Texas
Local Institution - 0022 Huntsville Texas
Local Institution - 0031 Wheeling West Virginia
Local Institution - 0003 Milwaukee Wisconsin
Local Institution - 0016 Leuven Vlaams Brabant
Local Institution - 0008 Roeselare West-Vlaanderen
Local Institution - 0023 Prague Praha, Hlavní Mesto
Local Institution - 0004 Prague Praha, Hlavní Mesto
Local Institution - 0041 Nice Alpes-Maritimes
Local Institution - 0001 Poitiers Vienne
Local Institution - 0026 Angers France
Local Institution - 0007 Grenoble France
Local Institution - 0046 Paris France
Local Institution - 0053 Pierre-Bénite France
Local Institution - 0044 Tour Cedex01 France
Local Institution - 0013 München Bavaria
Local Institution - 0040 Hanover Lower Saxony
Local Institution - 0009 Leipzig Saxony
Local Institution - 0021 Reggio Calabria Calabria
Local Institution - 0062 Naples Campania
Local Institution - 0050 Rome Lazio
Local Institution - 0015 Pavia Lombardy
Local Institution - 0029 Rozzano (MI) Milano
Local Institution - 0014 Novara Piedmont
Local Institution - 0045 Turin Piedmont
Local Institution - 0024 Florence Tuscany
Local Institution - 0049 Lódz Lódzkie
Local Institution - 0010 Warsaw Masovian Voivodeship

+ 12 more sites — see the full list on the official registry below.

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Other trials for the same condition

Institut Paoli Calmettes Myelodysplastic Syndromes Database Recruiting
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve Active, not recruiting
Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation Recruiting
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring Enrolling by invitation
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06045689 on ClinicalTrials.gov ↗ ← All trials in France