Clinical trial NCT00437450: Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
Official title: Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anemia in Myelodysplastic Syndromes
Keywords: Anemia
myelodysplastic syndromes
Low risk
Bone Marrow diseases
Lead sponsor: Groupe Francophone des Myelodysplasies
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
Secondary outcomes:
measure: To evaluate the tolerance of this treatment
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Avignon
country: France
facility: CHU d'Avignon
city: Bayonne
country: France
facility: CH de la cote Basque
city: Bobigny
country: France
facility: Hopital Avicenne
city: Caen
country: France
facility: CHU de Caen
city: Clamart
country: France
facility: Hopital Percy
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Albert Michallon
city: Limoges
country: France
facility: CHRU Limoges
city: Lyon
country: France
facility: CHU Edouard Herriot
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Nice
country: France
facility: CHU Archet
city: Paris
country: France
facility: Hopital Necker
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: HOPITAL Cochin
city: Paris
country: France
facility: Hopital Hotel Dieu
city: Quimper
country: France
facility: CH de Cournouaille
city: Reims
country: France
facility: CHU Robert Debre
city: Rouen
country: France
facility: Hopital Henri Becquerel
city: Strasbourg
country: France
facility: Hopital Hautepierre
city: Toulouse
country: France
facility: Chu Purpan
city: Tours
country: France
facility: CHU Bretoneau
city: Vandoeuvre-les-Nancy
country: France
facility: CHU Brabois
Study officials:
affiliation: Groupe Francophone des Myelodysplasies
name: Lionel ADES, MD
role: PRINCIPAL_INVESTIGATOR
References: