Overview

This trial is active, not recruiting.

Condition anemia in myelodysplastic syndromes
Treatment epoetin/atra
Phase phase 2
Sponsor Groupe Francophone des Myelodysplasies
Start date October 2004
End date September 2005
Trial size 99 participants
Trial identifier NCT00437450, 040759

Summary

The purpose of this study is

- To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes

- To evaluate the tolerance of this treatment

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
time frame:

Secondary Outcomes

Measure
To evaluate the tolerance of this treatment
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients ≥18 years with RA, RARS, RAEB (blasts <10%) - Hb< 10g/dl > of 2 months or transfused since less 2 months - Hb<12g/dl > of 2 months and thrombocytopenia defined by platelets < 50 000/mm3, or neutropenia<10 000mm3 - For women of child bearing age, necessity of contraception during all the duration of the study Exclusion Criteria: - Patient with lung disease, cardiac, neurological, gastro-intestinal or genito - urinary disorders not connected to genito -urinary not connected to myelodysplasia - Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol - RAEBt - RAEB >10% blasts - Treatment with rHu-Epo, darbepoetin ou rHu-GCSF , 2 months before inclusion - Patient presenting an iron , B12 vitamin or folic acid uncorrected deficit - CMML - Uncontrolled systemic hypertension - creatinine clearance < 300 µM/L - Pregnant patient or in period of lactation - Life expectancy < 6 months

Additional Information

Official title Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
Principal investigator Lionel ADES, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2009.
Information provided to ClinicalTrials.gov by Groupe Francophone des Myelodysplasies.