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

Myelodysplastic Syndromes Clinical Trial

— EPO-QoL  

Official title:

Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome With Analysis of the Impact on Quality of Life and Functional Capacity of Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428686
• Other study ID #: GFM EPO QoL
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2011
• Last updated: April 28, 2015
• Start date: June 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: Groupe Francophone des Myelodysplasies
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Epoetin beta (NeoRecormon)
Epoetin beta 60 000 IU/week

Locations

Country	Name	City	State
France	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	CHU de Bicêtre	Le Kremlin-Bicêtre	Ile de France
France	Centre Hospitalier du Mans	Le Mans cedex
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	Hopital Cochin	Paris
France	Hôpital Saint Louis	Paris
France	Hôpital Saint-Antoine.	Paris-Cedex 12
France	Hôpital Jean Bernard	Poitiers
France	Centre Hospitalier de la région d'Annecy	Pringy cedex
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

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Francophone des Myelodysplasies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No