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A Phase II Study of Maintenance With Azacitidine in MDS Patients

This study has been terminated.
Celgene Corporation
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies Identifier:
First received: March 9, 2007
Last updated: January 18, 2012
Last verified: June 2010

March 9, 2007
January 18, 2012
July 2006
July 2010   (final data collection date for primary outcome measure)
Reponse duration and cumulative incidence of relapses [ Time Frame: 1-24 months ] [ Designated as safety issue: Yes ]
reponse duration and cumulative incidence of relapses
Complete list of historical versions of study NCT00446303 on Archive Site
  • Toxicity according to WHO [ Time Frame: 1-24 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: Yes ]
  • toxicity according to WHO
  • overall survival
Not Provided
Not Provided
A Phase II Study of Maintenance With Azacitidine in MDS Patients
A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy

A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy.

The primary objective is response duration (MDS or AML)

A academic multicentre study whose aims are to study the benefits of a maintenance therapy with 24 monthly courses af azacytidine in high-risk MDS patients, previously treated with intensive chemotherapy with obtention of a partial or complete response and not eligible for allogeneic transplantation

Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia, Myelocytic, Acute
  • Myelodysplastic Syndromes
Drug: Azacitidine

Azacitidine 60mg/m2 /d for 5 days every 28 days, for 24 months (parallel study to the ongoing NMDSG study.

Extension of maintenance in responders after 24 courses until relapse or death.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • MDS with int 2 or high IPSS score eitherRAEB 1 or 2 according to the WHO classification (see appendix 1) or CMML with WBC < 13 109/l RAEB-T according to the FAB classification (see appendix 1) without t(8 ;21), inv 16 or t(16;16) AML secondary to MDS (sAML) with a confirmed MDS phase of at least 2 months with available bone marrow cytogenetics at diagnosis of AML


in CR or PR according to IWG criteria (see appendix 3) after one or two courses of predefined intensive chemotherapy (see page 12) with available cytogenetics at evaluation of response Aged 18 years of age or more Written Informed consent Adequate Contraception, if relevant Negative pregnancy test if relevant. Patients not eligible for the azacitidine confirmatory trial (azacitidine " versus " conventional treatment ") or unwilling to participate to it

Exclusion Criteria:

  • AML secondary to myeloproliferative or MDS/MPD WHO subgroups except CMML with WBC< 13 109/l
  • Therapy related MDS (after chemo or radiotherapy for a previous neoplasm or immune disorder)
  • Patients eligible for allogeneic bone marrow transplantation (with a identified donor)
  • Liver and/or kidney failures prohibiting the use of azacitidine. Creatininemia > 1.5 normal value ALAT and ASAT > 3N
  • Bilirubin > 2 N, unless due to dyserythropoiesis
  • Known hypersensitivity to azacitidine or mannitol
  • Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
  • Uncontrolled infection,
  • WHO Performance status > 2
  • Life expectancy less than 3 months
18 Years to 85 Years
Contact information is only displayed when the study is recruiting subjects
GFM aza05
Groupe Francophone des Myelodysplasies
Groupe Francophone des Myelodysplasies
Celgene Corporation
Principal Investigator: Claude GARDIN, MD Groupe Francophone des Myelodysplasies
Groupe Francophone des Myelodysplasies
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP