Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome (MDS)
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Drug: Epoetin beta (NeoRecormon)
- Registration Number
- NCT02428686
- Lead Sponsor
- Groupe Francophone des Myelodysplasies
- Brief Summary
Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. It generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. The historical treatment is limited to transfusion support with a significant impact on quality of life and the incidence of secondary haemosiderosis, which contributes to the emergence of co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid response in 40-60% of patients treated.
In this trial, the investigators intend to study the interest of a treatment with epoetin beta in patients with anemia \<10 g / dL in the context of a myelodysplastic syndrome with IPSS score \<1.
In addition to studying the erythroid response, the investigators will measure the impact on quality of life and functional performance.
Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24 weeks of treatment.
- Detailed Description
Objective of the trial Assess the level of haematological response according to IWG 2000 and IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment;
To evaluate the predictive value of the rate of reticulocytes at Day 8 on the erythroid response;
* Assess time to response
* Assess tolerance
* Assess the impact on quality of life using the FACT-An and EQ-5D measurement scales;
* Assess functional capacity:
Cardiovascular performance on effort by the 6-minute walk test Performing the " Short Physical Performance Battery " tests
Evaluation The evaluation of response according to the IWG 2000 and IWG 2006 criteria will be held at 12 and 24 weeks of treatment
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Written informed consent
- Must be 18 years of age or older at the time of screening
- Myelodysplastic Syndrome of the following subtypes : RA, RAS, RCMD, RCMD-RS, RAEB 1, with IPSS score low or intermediate 1 (IPSS score < 1 ) and with anemia defined by Hb < 10 g/dl (with RBC transfusion requirement or not)
- For women of childbearing potential, need for effective contraception throughout the study period.
- Intensive Chemotherapy within 3 months before inclusion
- Myelodysplastic Syndrome with IPSS score >1
- Treatment with rHu-Epo or rHu-GCSF within 2 months before inclusion
- EGOG > 3 ;
- Other causes of anemia (eg. , Iron deficiency, vitamin B12 or folic acid, hypothyroidism before correction)
- Uncontrolled arterial hypertension
- Life expectancy less than 6 months
- CMML
- Pregnant or breast feeding female subjects
- Patients with creatinine clearance less than 30ml/min.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description epoetin beta Epoetin beta (NeoRecormon) -
- Primary Outcome Measures
Name Time Method Assess the level of haematological response according to IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment 12 and 24 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
Hôpital Américain de Paris
🇫🇷Neuilly Sur Seine, France
CHU de Reims
🇫🇷Reims, France
Hopital de la Cote Basque
🇫🇷Bayonne, France
Hôpital Avicenne
🇫🇷Bobigny, France
CHRU de Limoges
🇫🇷Limoges, France
Hematology Dpt, Hopital de l'Hotel Dieu
🇫🇷Nantes, France
centre hospitalier de Mantes-la-jolie
🇫🇷Mantes-la-jolie, France
CHU Brabois
🇫🇷Nancy, France
CHU Archet
🇫🇷Nice, France
Hôpital La Source
🇫🇷Orléans, France
Hôpital Saint-Antoine.
🇫🇷Paris-Cedex 12, France
CHU de Bicêtre
🇫🇷Le Kremlin-Bicêtre, Ile de France, France
Hôpital Boulogne Sur Mer
🇫🇷Boulogne Sur Mer, France
Hôpital Jean Bernard
🇫🇷Poitiers, France
Centre Hospitalier Universitaire de STRASBOURG
🇫🇷Strasbourg, France
CHU d'AMIENS
🇫🇷Amiens, France
CHU de Brest
🇫🇷Brest, France
Centre Hospitalier de la région d'Annecy
🇫🇷Pringy cedex, France
Hôpital Saint Louis
🇫🇷Paris, France
Chu Purpan
🇫🇷Toulouse, France
CHU Clémenceau
🇫🇷Caen, France
Institut Paoli Calmette
🇫🇷Marseille, France
Centre Henri Becquerel
🇫🇷Rouen, France
Hopital Bretonneau
🇫🇷Tours, France
CH Angers
🇫🇷Angers, France
CH d'Avignon-305 rue Follereau-
🇫🇷Avignon, France
CH René Dubos
🇫🇷Cergy-pontoise, France
Centre Hospitalier du Mans
🇫🇷Le Mans cedex, France
CHRU Huriez
🇫🇷Lille, France
Hopital Saint-Vincent de Paul-
🇫🇷Lille, France
Hopital Cochin
🇫🇷Paris, France