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

This study is ongoing, but not recruiting participants.

First Received: February 19, 2007 No Changes Posted

Sponsor:	Groupe Francophone des Myelodysplasies
Information provided by:	Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:	NCT00437450

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Anemia Bone Marrow Diseases

Drug Information available for: Erythropoietin Epoetin alfa Epoetin beta Tretinoin

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:

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

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437450

Locations

Sponsors and Collaborators

Groupe Francophone des Myelodysplasies

Investigators

Principal Investigator:

Lionel ADES, MD

Groupe Francophone des Myelodysplasies

More Information

No publications provided

Study ID Numbers:	040759
Study First Received:	February 19, 2007
Last Updated:	February 19, 2007
ClinicalTrials.gov Identifier:	NCT00437450 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Francophone des Myelodysplasies:

Anemia
myelodysplastic syndromes
Low risk
Bone Marrow diseases

Additional relevant MeSH terms:

Disease
Precancerous Conditions
Hematologic Diseases
Antineoplastic Agents
Myelodysplastic Syndromes
Anemia
Pharmacologic Actions
Keratolytic Agents

Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses
Tretinoin
Bone Marrow Diseases
Dermatologic Agents

ClinicalTrials.gov processed this record on November 11, 2009