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

Sponsor

Groupe Francophone des Myelodysplasies (Other)

Overall Status

Unknown status

CT.gov ID

NCT00437450

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Anemia in Myelodysplastic Syndromes	Drug: Epoetin/Atra	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2004

Study Completion Date :

Sep 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	CHU d'Amiens	Amiens	France	84054
2	CHU d'Angers	Angers	France	43033
3	CHU d'Avignon	Avignon	France	84000
4	CH de la cote Basque	Bayonne	France	64100
5	Hopital Avicenne	Bobigny	France	93009
6	CHU de Caen	Caen	France	14033
7	Hopital Percy	Clamart	France	92140
8	CHU Dijon	Dijon	France	21000
9	CHU Albert Michallon	Grenoble	France	38043
10	CHRU Limoges	Limoges	France	87046
11	CHU Edouard Herriot	Lyon	France	69437
12	Institut Paoli Calmette	Marseille	France	13009
13	CHU Archet	Nice	France	06202
14	Hopital Necker	Paris	France	75010
15	Hopital Saint Antoine	Paris	France	75012
16	HOPITAL Cochin	Paris	France	75014
17	Hopital Hotel Dieu	Paris	France	75181
18	CH de Cournouaille	Quimper	France	29107
19	CHU Robert Debre	Reims	France	51092
20	Hopital Henri Becquerel	Rouen	France	76038
21	Hopital Hautepierre	Strasbourg	France	67098
22	Chu Purpan	Toulouse	France	31059
23	CHU Bretoneau	Tours	France	37044
24	CHU Brabois	Vandoeuvre-les-Nancy	France	54511