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A Phase II Study of Maintenance With Azacitidine in MDS Patients

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ClinicalTrials.gov Identifier: NCT00446303
Recruitment Status : Terminated
First Posted : March 12, 2007
Last Update Posted : January 19, 2012
Celgene Corporation
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies

Brief Summary:

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)

Condition or disease Intervention/treatment Phase
Leukemia, Myelocytic, Acute Myelodysplastic Syndromes Drug: Azacitidine Phase 2

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy
Study Start Date : July 2006
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine
U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. Reponse duration and cumulative incidence of relapses [ Time Frame: 1-24 months ]

Secondary Outcome Measures :
  1. Toxicity according to WHO [ Time Frame: 1-24 months ]
  2. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446303

CHU d'Amiens
Amiens, France, 80054
CHU Angers
Angers, France, 49033
CH d'Avignon
Avignon, France, 84000
CHU de Caen
Caen, France, 14033
Hopital d'Instruction des Armées Percy
Clamart, France, 92140
Hopital Henri Mondor
Creteil, France, 94000
CHU de Dijon
Dijon, France, 21034
CHU Albert Michallon
Grenoble, France, 38043
CHRU Hurriez
Lille, France, 59057
CHRU de Limoges
Limoges, France, 87046
Hopital Edouard Herriot
Lyon, France, 69437
Hopital Paoli Calmette
Marseille, France, 13273
Hopital Hotel Dieu
Nantes, France, 44093
Hopital Archet
Nice, France, 06202
Hopital Saint Louis
Paris, France, 75475
Hopital Saint Antoine
Paris, France, 75571
Hopital Cochin
Paris, France, 75679
Hopital Haut Leveque
Pessac, France, 33604
Hopital Jean-Bernard
Poitiers, France, 86021
CHRU de Reims
Reims, France, 51092
CHU Pontchaillou
Rennes, France, 35033
Hopital Hautepierre
Strasbourg, France, 67098
Hopital Purpan
Toulouse, France, 31031
CHU Brabois
Vandoeuvre, France, 54511
CH Versailles
Versailles, France, 78000
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Celgene Corporation
Principal Investigator: Claude GARDIN, MD Groupe Francophone des Myelodysplasies

Responsible Party: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier: NCT00446303     History of Changes
Other Study ID Numbers: GFM aza05
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: June 2010

Keywords provided by Groupe Francophone des Myelodysplasies:
Myelodysplastic Syndromes
Intensive chemotherapy

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors