Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome (MDS)

NCT ID: NCT02428686

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-03-31

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.

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

Conditions

Myelodysplastic Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

epoetin beta

Group Type: EXPERIMENTAL

Epoetin beta (NeoRecormon)

Intervention Type: DRUG

Epoetin beta 60 000 IU/week

Interventions

Epoetin beta (NeoRecormon)

Epoetin beta 60 000 IU/week

Intervention Type: DRUG

Other Intervention Names

NeoRecormon

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Francophone des Myelodysplasies

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU d'AMIENS

Amiens, , France

CH Angers

Angers, , France

CH d'Avignon-305 rue Follereau-

Avignon, , France

Hopital de la Cote Basque

Bayonne, , France

Hôpital Avicenne

Bobigny, , France

Hôpital Boulogne Sur Mer

Boulogne-sur-Mer, , France

CHU de Brest

Brest, , France

CHU Clémenceau

Caen, , France

CH René Dubos

Cergy-Pontoise, , France

Centre Hospitalier du Mans

Le Mans, , France

CHRU Huriez

Lille, , France

Hopital Saint-Vincent de Paul-

Lille, , France

CHRU de Limoges

Limoges, , France

centre hospitalier de Mantes-la-jolie

Mantes-la-Jolie, , France

Institut Paoli Calmette

Marseille, , France

CHU Brabois

Nancy, , France

Hematology Dpt, Hopital de l'Hotel Dieu

Nantes, , France

Hôpital Américain de Paris

Neuilly-sur-Seine, , France

CHU Archet

Nice, , France

Hôpital La Source

Orléans, , France

Hôpital Saint Louis

Paris, , France

Hôpital Saint-Antoine.

Paris, , France

Hopital Cochin

Paris, , France

Hôpital Jean Bernard

Poitiers, , France

Centre Hospitalier de la région d'Annecy

Pringy, , France

CHU de Reims

Reims, , France

Centre Henri Becquerel

Rouen, , France

Centre Hospitalier Universitaire de STRASBOURG

Strasbourg, , France

Chu Purpan

Toulouse, , France

Hopital Bretonneau

Tours, , France

CHU de Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, France

Countries

France

Other Identifiers

GFM EPO QoL

Identifier Type: -

Identifier Source: org_study_id