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

November 17, 2009 updated by: Groupe Francophone des Myelodysplasies

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 84054
        • CHU d'Amiens
      • Angers, France, 43033
        • CHU d'Angers
      • Avignon, France, 84000
        • CHU d'Avignon
      • Bayonne, France, 64100
        • CH de la Cote Basque
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Caen, France, 14033
        • CHU de Caen
      • Clamart, France, 92140
        • Hôpital Percy
      • Dijon, France, 21000
        • CHU Dijon
      • Grenoble, France, 38043
        • CHU Albert Michallon
      • Limoges, France, 87046
        • CHRU Limoges
      • Lyon, France, 69437
        • Chu Edouard Herriot
      • Marseille, France, 13009
        • Institut Paoli Calmette
      • Nice, France, 06202
        • CHU Archet
      • Paris, France, 75012
        • Hôpital Saint Antoine
      • Paris, France, 75014
        • Hopital Cochin
      • Paris, France, 75181
        • Hôpital Hotel Dieu
      • Paris, France, 75010
        • Hopital Necker
      • Quimper, France, 29107
        • CH de Cournouaille
      • Reims, France, 51092
        • CHU Robert Debré
      • Rouen, France, 76038
        • Hopital Henri Becquerel
      • Strasbourg, France, 67098
        • Hôpital Hautepierre
      • Toulouse, France, 31059
        • CHU Purpan
      • Tours, France, 37044
        • CHU Bretoneau
      • Vandoeuvre-les-Nancy, France, 54511
        • CHU Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
To evaluate the tolerance of this treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Francophone des Myelodysplasies

Investigators

  • Principal Investigator: Lionel ADES, MD, Groupe Francophone des Myelodysplasies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

February 19, 2007

First Submitted That Met QC Criteria

February 19, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Estimate)

November 18, 2009

Last Update Submitted That Met QC Criteria

November 17, 2009

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 040759

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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