Actively Recruiting
Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA
Led by Groupe Francophone des Myelodysplasies · Updated on 2026-03-05
150
Participants Needed
40
Research Sites
369 weeks
Total Duration
On this page
Sponsors
G
Groupe Francophone des Myelodysplasies
Lead Sponsor
C
Celgene
Collaborating Sponsor
AI-Summary
What this Trial Is About
Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA
CONDITIONS
Official Title
Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myelodysplastic syndrome according to current WHO classification
- Age 18 years or older
- Lower-risk MDS (LOW, INT-1) without ring sideroblasts who failed to respond or relapsed after ESA treatment or are ineligible for ESA (EPO > 500 UI/l)
- Hemoglobin less than 9 g/dL or transfusion dependent (at least 3 red blood cell transfusions in 16 weeks with at least 2 transfusion episodes)
- No del(5q) syndrome
- Adequate kidney function (creatinine less than 1.5 times upper limit of normal, creatinine clearance ≥ 40 mL/min)
- Adequate liver function (total bilirubin and transaminases less than 1.5 times upper limit of normal)
- Not refractory to platelet transfusions
- Able to provide written informed consent
- Ability to comply with visit schedule and protocol
- ECOG performance status 0-2 at screening
- Female participants of childbearing potential must have negative pregnancy tests and agree to effective contraception
- Male participants must agree to use condoms during study and for 12 weeks after treatment discontinuation
You will not qualify if you...
- Severe infection or other uncontrolled severe conditions
- Uncontrolled hypertension
- Significant cardiac disease (NYHA Class III or IV or recent myocardial infarction within 6 months)
- Presence of del(5q) syndrome
- Use of investigational agents within 30 days or anticancer therapy within 2 weeks before study entry (except hydroxyurea)
- Use of erythropoietin within 4 weeks before study entry
- Active cancer or cancer within past year except certain skin or cervical cancers
- Participation in another investigational drug trial
- Known HIV infection or active hepatitis B or C
- Women who are pregnant or breastfeeding
- Any medical or psychiatric condition preventing informed consent
- Eligible for allogeneic stem cell transplantation
- Known allergies to luspatercept, erythropoietin, or their components
- Lack of health insurance affiliation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
CHU Amiens-Picardie
Amiens, France, 80054
Actively Recruiting
2
Clinique de l'Europe
Amiens, France, 80090
Not Yet Recruiting
3
CHU Angers
Angers, France, 49933
Actively Recruiting
4
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Actively Recruiting
5
CH Henri Duffaut d'Avignon
Avignon, France, 84000
Actively Recruiting
6
Centre Hospitalier de la Côte Basque
Bayonne, France, 64109
Not Yet Recruiting
7
Hôpital Avicenne
Bobigny, France, 93009
Actively Recruiting
8
Hôpital Privé Sévigné
Cesson-Sévigné, France, 35510
Actively Recruiting
9
CHU de Grenoble
Grenoble, France, 38043
Actively Recruiting
10
Centre Hospitalier de Versailles
Le Chesnay, France, 78150
Not Yet Recruiting
11
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
12
CH Le Mans
Le Mans, France, 72037
Actively Recruiting
13
CHRU de Lille - Hôpital Claude Huriez
Lille, France, 59037
Not Yet Recruiting
14
CHRU de Limoges - Hôpital Dupuytren
Limoges, France, 87042
Not Yet Recruiting
15
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan, France, 40000
Not Yet Recruiting
16
CHU Saint Eloi
Montpellier, France, 34295
Actively Recruiting
17
CHU Nantes - Hôtel Dieu
Nantes, France, 44093
Actively Recruiting
18
Hôpital privé du Confluent
Nantes, France, 44277
Actively Recruiting
19
CHU de Nice - Hôpital Archet 1
Nice, France, 06202
Actively Recruiting
20
CHU de Nîmes
Nîmes, France, 30029
Actively Recruiting
21
CHR d'Orléans
Orléans, France, 45067
Actively Recruiting
22
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
23
Hôpital Cochin
Paris, France, 75014
Not Yet Recruiting
24
Hôpital Necker
Paris, France, 75015
Actively Recruiting
25
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, France, 33604
Actively Recruiting
26
Centre Hospitalier de Périgueux
Périgueux, France, 24019
Actively Recruiting
27
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Not Yet Recruiting
28
CHU de Poitiers
Poitiers, France, 86021
Actively Recruiting
29
Hôpital NOVO
Pontoise, France, 95300
Not Yet Recruiting
30
Centre Hospitalier de Cornouaille
Quimper, France, 29107
Not Yet Recruiting
31
CHU de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
32
Centre Henri Becquerel
Rouen, France, 76038
Actively Recruiting
33
Institut de Cancérologie et d'Hématologie Universitaire de Saint-Etienne
Saint-Priest-en-Jarez, France, 42271
Actively Recruiting
34
Strasbourg Oncologie Libérale Clinique Sainte Anne
Strasbourg, France, 67000
Actively Recruiting
35
CHU Toulouse - IUCT Oncopole
Toulouse, France, 31059
Actively Recruiting
36
CHU de Tours - Hôpital Bretonneau
Tours, France, 37000
Actively Recruiting
37
Centre Hospitalier de Valence
Valence, France, 26000
Actively Recruiting
38
CHRU Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
39
IRCCS
Candiolo, Italy, 10060
Actively Recruiting
40
AOU Careggi
Florence, Italy, 50134
Not Yet Recruiting
Research Team
F
Fatiha CHERMAT
CONTACT
K
Karine LEMARIE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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