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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00437450 |
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Date of registration:
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19/02/2007 |
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Primary sponsor: |
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Public title:
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Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
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Scientific title:
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Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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99 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00437450 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Lionel ADES, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Groupe Francophone des Myelodysplasies |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia in Myelodysplastic Syndromes
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Intervention(s)
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Drug: Epoetin/Atra
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Primary Outcome(s)
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To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
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Secondary Outcome(s)
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To evaluate the tolerance of this treatment
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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