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

NCT ID: NCT00437450

Last Updated: 2009-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Anemia in Myelodysplastic Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Epoetin/Atra

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Francophone des Myelodysplasies

OTHER

Sponsor Role lead

Principal Investigators

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Lionel ADES, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Francophone des Myelodysplasies

Locations

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CHU d'Amiens

Amiens, , France

Site Status

CHU d'Angers

Angers, , France

Site Status

CHU d'Avignon

Avignon, , France

Site Status

CH de la cote Basque

Bayonne, , France

Site Status

Hopital Avicenne

Bobigny, , France

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CHU de Caen

Caen, , France

Site Status

Hopital Percy

Clamart, , France

Site Status

CHU Dijon

Dijon, , France

Site Status

CHU Albert Michallon

Grenoble, , France

Site Status

CHRU Limoges

Limoges, , France

Site Status

CHU Edouard Herriot

Lyon, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

CHU Archet

Nice, , France

Site Status

Hopital Necker

Paris, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

HOPITAL Cochin

Paris, , France

Site Status

Hopital Hotel Dieu

Paris, , France

Site Status

CH de Cournouaille

Quimper, , France

Site Status

CHU Robert Debre

Reims, , France

Site Status

Hopital Henri Becquerel

Rouen, , France

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Hopital Hautepierre

Strasbourg, , France

Site Status

Chu Purpan

Toulouse, , France

Site Status

CHU Bretoneau

Tours, , France

Site Status

CHU Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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040759

Identifier Type: -

Identifier Source: org_study_id

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