Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
Information source: Groupe Francophone des Myelodysplasies
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anemia in Myelodysplastic Syndromes
Intervention: Epoetin/Atra (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Groupe Francophone des Myelodysplasies Official(s) and/or principal investigator(s):
Lionel ADES, MD, Principal Investigator, Affiliation: Groupe Francophone des Myelodysplasies
Summary
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
Clinical Details
Official title: Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
Secondary outcome: To evaluate the tolerance of this treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hopital Avicenne, Bobigny 93009, France
CHU d'Amiens, Amiens 84054, France
CHU d'Angers, Angers 43033, France
CH de la cote Basque, Bayonne 64100, France
Hopital Percy, Clamart 92140, France
CHU d'Avignon, Avignon 84000, France
CHU Dijon, Dijon 21000, France
CHU Albert Michallon, Grenoble 38043, France
CHRU Limoges, Limoges 87046, France
CHU Edouard Herriot, Lyon 69437, France
Institut Paoli Calmette, Marseille 13009, France
CHU Archet, Nice 06202, France
HOPITAL Cochin, Paris 75014, France
Hopital Necker, Paris 75010, France
Hopital Hotel Dieu, Paris 75181, France
Hopital Saint Antoine, Paris 75012, France
CH de Cournouaille, Quimper 29107, France
CHU Robert Debre, Reims 51092, France
Hopital Henri Becquerel, Rouen 76038, France
Hopital Hautepierre, Strasbourg 67098, France
CHU PURPAN, Toulouse 31059, France
CHU Bretoneau, Tours 37044, France
CHU Brabois, Vandoeuvre-les-Nancy 54511, France
CHU de Caen, Caen 14033, France
Additional Information
Starting date: October 2004
Ending date: September 2005
Last updated: February 19, 2007
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