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
Recruitment status was Active, not recruiting
Sponsor:
Groupe Francophone des Myelodysplasies
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 22, 2013