Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid - Tabular View

Tracking Information

First Received Date ^ICMJE

February 19, 2007

Last Updated Date

November 17, 2009

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00437450 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the tolerance of this treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

Official Title ^ICMJE

Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

Brief 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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Anemia in Myelodysplastic Syndromes

Intervention ^ICMJE

Drug: Epoetin/Atra

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

September 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00437450

Responsible Party

Study ID Numbers ^ICMJE

040759

Study Sponsor ^ICMJE

Groupe Francophone des Myelodysplasies

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Lionel ADES, MD

Groupe Francophone des Myelodysplasies

Information Provided By

Groupe Francophone des Myelodysplasies

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP