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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Groupe Francophone des Myelodysplasies.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437450
First Posted: February 21, 2007
Last Update Posted: November 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Groupe Francophone des Myelodysplasies
  Purpose

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

Condition Intervention Phase
Anemia in Myelodysplastic Syndromes Drug: Epoetin/Atra Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

Resource links provided by NLM:


Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:
  • To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes

Secondary Outcome Measures:
  • To evaluate the tolerance of this treatment

Estimated Enrollment: 99
Study Start Date: October 2004
Estimated Study Completion Date: September 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437450


Locations
France
CHU d'Amiens
Amiens, France, 84054
CHU d'Angers
Angers, France, 43033
CHU d'Avignon
Avignon, France, 84000
CH de la cote Basque
Bayonne, France, 64100
Hopital Avicenne
Bobigny, France, 93009
CHU de Caen
Caen, France, 14033
Hopital Percy
Clamart, France, 92140
CHU Dijon
Dijon, France, 21000
CHU Albert Michallon
Grenoble, France, 38043
CHRU Limoges
Limoges, France, 87046
CHU Edouard Herriot
Lyon, France, 69437
Institut Paoli Calmette
Marseille, France, 13009
CHU Archet
Nice, France, 06202
Hopital Necker
Paris, France, 75010
Hopital Saint Antoine
Paris, France, 75012
HOPITAL Cochin
Paris, France, 75014
Hopital Hotel Dieu
Paris, France, 75181
CH de Cournouaille
Quimper, France, 29107
CHU Robert Debre
Reims, France, 51092
Hopital Henri Becquerel
Rouen, France, 76038
Hopital Hautepierre
Strasbourg, France, 67098
Chu Purpan
Toulouse, France, 31059
CHU Bretoneau
Tours, France, 37044
CHU Brabois
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Investigators
Principal Investigator: Lionel ADES, MD Groupe Francophone des Myelodysplasies
  More Information

ClinicalTrials.gov Identifier: NCT00437450     History of Changes
Other Study ID Numbers: 040759
First Submitted: February 19, 2007
First Posted: February 21, 2007
Last Update Posted: November 18, 2009
Last Verified: February 2007

Keywords provided by Groupe Francophone des Myelodysplasies:
Anemia
myelodysplastic syndromes
Low risk
Bone Marrow diseases

Additional relevant MeSH terms:
Syndrome
Anemia
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Neoplasms
Epoetin Alfa
Tretinoin
Hematinics
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents