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

Information source: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndromes

Intervention: Epoetin beta (NeoRecormon) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Groupe Francophone des Myelodysplasies

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.

Clinical Details

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

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

Primary outcome: 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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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 cedex 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-Antoine., Paris-Cedex 12 75571, France

Hopital Cochin, Paris 75679, France

Hôpital Saint Louis, Paris 75475, France

Hôpital Jean Bernard, Poitiers 86021, France

Centre Hospitalier de la région d'Annecy, Pringy cedex 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, Ile de France 94275, France

Additional Information

Starting date: June 2010
Last updated: April 28, 2015

Page last updated: August 20, 2015

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