Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome (MDS)
EPO-QoL
1 other identifier
interventional
50
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2010
Typical duration for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedApril 29, 2015
April 1, 2015
3.8 years
November 24, 2011
April 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
epoetin beta
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Myelodysplastic Syndrome with IPSS score \>1
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
CHU d'AMIENS
Amiens, 80054, France
CH Angers
Angers, 49 000, France
CH d'Avignon-305 rue Follereau-
Avignon, 84000, France
Hopital de la Cote Basque
Bayonne, 64100, France
Hôpital Avicenne
Bobigny, 93 000, France
Hôpital Boulogne Sur Mer
Boulogne-sur-Mer, 62321, France
CHU de Brest
Brest, 29609, France
CHU Clémenceau
Caen, 14033, France
CH René Dubos
Cergy-Pontoise, 95303, France
Centre Hospitalier du Mans
Le Mans, 72037, France
CHRU Huriez
Lille, 59037, France
Hopital Saint-Vincent de Paul-
Lille, 59160, France
CHRU de Limoges
Limoges, 87046, France
centre hospitalier de Mantes-la-jolie
Mantes-la-Jolie, 78201, France
Institut Paoli Calmette
Marseille, 13273, France
CHU Brabois
Nancy, 54511, France
Hematology Dpt, Hopital de l'Hotel Dieu
Nantes, 44093, France
Hôpital Américain de Paris
Neuilly-sur-Seine, 92200, France
CHU Archet
Nice, 06202, France
Hôpital La Source
Orléans, 45067, France
Hôpital Saint Louis
Paris, 75475, France
Hôpital Saint-Antoine.
Paris, 75571, France
Hopital Cochin
Paris, 75679, France
Hôpital Jean Bernard
Poitiers, 86021, France
Centre Hospitalier de la région d'Annecy
Pringy, 74374, France
CHU de Reims
Reims, 51092, France
Centre Henri Becquerel
Rouen, 76038, France
Centre Hospitalier Universitaire de STRASBOURG
Strasbourg, 67098, France
Chu Purpan
Toulouse, 31059, France
Hopital Bretonneau
Tours, 37044, France
CHU de Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94275, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2011
First Posted
April 29, 2015
Study Start
June 1, 2010
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
April 29, 2015
Record last verified: 2015-04