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A Phase II Study of Maintenance With Azacitidine in MDS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00446303
Recruitment Status : Terminated
First Posted : March 12, 2007
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
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

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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
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine


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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

AND

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


Locations
Show Show 25 study locations
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Celgene Corporation
Investigators
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Principal Investigator: Claude GARDIN, MD Groupe Francophone des Myelodysplasies
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Responsible Party: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier: NCT00446303    
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:
MDS
Myelodysplastic Syndromes
AML
Intensive chemotherapy
azacitidine
Additional relevant MeSH terms:
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Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Leukemia
Neoplasms by Histologic Type
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors