search
Back to results

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

Primary Purpose

Anemia in Myelodysplastic Syndromes

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Epoetin/Atra
Sponsored by
Groupe Francophone des Myelodysplasies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia in Myelodysplastic Syndromes focused on measuring Anemia, myelodysplastic syndromes, Low risk, Bone Marrow diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU d'Amiens
  • CHU d'Angers
  • CHU d'Avignon
  • CH de la cote Basque
  • Hopital Avicenne
  • CHU de Caen
  • Hopital Percy
  • CHU Dijon
  • CHU Albert Michallon
  • CHRU Limoges
  • CHU Edouard Herriot
  • Institut Paoli Calmette
  • CHU Archet
  • Hopital Necker
  • Hopital Saint Antoine
  • HOPITAL Cochin
  • Hopital Hotel Dieu
  • CH de Cournouaille
  • CHU Robert Debre
  • Hopital Henri Becquerel
  • Hopital Hautepierre
  • Chu Purpan
  • CHU Bretoneau
  • CHU Brabois

Outcomes

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

Full Information

First Posted
February 19, 2007
Last Updated
November 17, 2009
Sponsor
Groupe Francophone des Myelodysplasies
search

1. Study Identification

Unique Protocol Identification Number
NCT00437450
Brief Title
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

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Groupe Francophone des Myelodysplasies

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia in Myelodysplastic Syndromes
Keywords
Anemia, myelodysplastic syndromes, Low risk, Bone Marrow diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Epoetin/Atra
Primary Outcome Measure Information:
Title
To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
Secondary Outcome Measure Information:
Title
To evaluate the tolerance of this treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lionel ADES, MD
Organizational Affiliation
Groupe Francophone des Myelodysplasies
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Amiens
City
Amiens
ZIP/Postal Code
84054
Country
France
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
43033
Country
France
Facility Name
CHU d'Avignon
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
CH de la cote Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Percy
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU Albert Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU Limoges
City
Limoges
ZIP/Postal Code
87046
Country
France
Facility Name
CHU Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CHU Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
HOPITAL Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Hotel Dieu
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
CH de Cournouaille
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
CHU Robert Debre
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hopital Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Hopital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Chu Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Bretoneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU Brabois
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs