Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA
NCT ID: NCT05181735
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2022-05-18
2029-06-19
Brief Summary
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Detailed Description
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Part B : Determination of the superiority and efficacy of the association Luspatercept+ESA (erythroipoiesis Stimulating Agent) over luspatercept alone in patients with lower risk MDS who failed to achieve a response or who subsequently relapsed after ESA, wihtout disease progression
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Luspatercept alone)
Patients will receive Luspatercept 1mg/kg (every 3 weeks) with titration up to max of 1.75mg/kg, subcutaneously on day 1 of each 21 day cycle (every three weeks).
Luspatercept 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
Arm B (Luspatercept + EPREX)
Patients will receive Luspatercept (at the selected dose according to part A) subcutaneously on day 1 of each 21 day cycle (every three weeks) AND Epoetin alfa: At the selected dose (in part A) per week, subcutaneously, every week
Doses schedules Part A :
* Level 1 : Luspatercept 0.8 mg/kg + EPREX 30000 UI
* Level 2 : Luspatercept 1.33 mg/kg + EPREX 30000 UI
* Level 3 : Luspatercept 1.75mg/kg + EPREX 30000 UI
* Level 4 : Luspatercept 1.75mg/kg + EPREX 60000 UI
Luspatercept 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
Eprex
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
Interventions
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Luspatercept 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
Eprex
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Groupe Francophone des Myelodysplasies
OTHER
Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Lionel ADES, Pr.
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint Louis
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-000596-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
COMBOLA
Identifier Type: -
Identifier Source: org_study_id
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