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 because the information has not been verified recently.
Verified February 2007 by Groupe Francophone des Myelodysplasies.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:
NCT00437450
First received: February 19, 2007
Last updated: November 17, 2009
Last verified: February 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Saint Antoine
Paris, France, 75012
Hopital Hotel Dieu
Paris, France, 75181
Hopital Necker
Paris, France, 75010
HOPITAL Cochin
Paris, France, 75014
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

No publications provided

ClinicalTrials.gov Identifier: NCT00437450     History of Changes
Other Study ID Numbers: 040759
Study First Received: February 19, 2007
Last Updated: November 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Anemia
Myelodysplastic Syndromes
Preleukemia
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Neoplasms
Epoetin Alfa
Tretinoin
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 23, 2014