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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Anemia in Myelodysplastic Syndromes

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Lionel ADES, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Francophone des Myelodysplasies

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

040759

NCT ID:

NCT00437450

Start Date:

October 2004

Completion Date:

September 2005

Related Keywords:

  • Anemia in Myelodysplastic Syndromes
  • Anemia
  • myelodysplastic syndromes
  • Low risk
  • Bone Marrow diseases
  • Anemia
  • Myelodysplastic Syndromes
  • Preleukemia

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