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A Phase II Study of Maintenance With Azacitidine in MDS Patients
This study is currently recruiting participants.
Verified by Groupe Francophone des Myelodysplasies, November 2006
Sponsored by: Groupe Francophone des Myelodysplasies
Information provided by: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier: NCT00446303
  Purpose

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 Intervention Phase
Leukemia, Myelocytic, Acute
Myelodysplastic Syndromes
Drug: Azacitidine
Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Azacitidine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy

Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:
  • reponse duration and cumulative incidence of relapses

Secondary Outcome Measures:
  • toxicity according to WHO
  • overall survival

Estimated Enrollment: 39
Study Start Date: July 2006
Estimated Study Completion Date: July 2010
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446303

Contacts
Contact: Claude GARDIN, MD 0033148957054 claude.gardin@avc.aphp.fr
Contact: Fatima-Zohra HAMZA, CRA 0033148955890 fatima.hamza@avc.aphp.fr

Locations
France
CHU d'Amiens Recruiting
Amiens, France, 80054
Contact: Ghandi DAMAJ     0033322455915     damaj.Gandhi@chu-amiens.fr    
Principal Investigator: DAMAJ, MD            
CHU Angers Terminated
Angers, France, 49033
CH d'Avignon Not yet recruiting
Avignon, France, 84000
Contact: Borhane SLAMA, MD     0033432753132     bslama@ch-avignon.fr    
Principal Investigator: SLAMA, MD            
Hopital Haut Leveque Suspended
Pessac, France, 33604
CHU de Caen Recruiting
Caen, France, 14033
Contact: Stéphane CHEZE, MD     0033231272360     cheze-s@chu-caen.fr    
Principal Investigator: CHEZE, MD            
Hopital d'Instruction des Armées Percy Not yet recruiting
Clamart, France, 92140
Contact: Thierry DE REVEL, Profesor     0033141466301     hematologie.percy@wanadoo.fr    
Principal Investigator: DE REVEL, Professor            
Hopital Henri Mondor Recruiting
Creteil, France, 94000
Contact: Catherine CORDONNIER     0033149812057     carlcord@club-internet.fr    
Sub-Investigator: MATHIEU KUENTZ, MD            
Sub-Investigator: SEBASTIEN MAURY, MD            
Sub-Investigator: CECILE PAUTAS, MD            
Sub-Investigator: STEPHANE GIRAUDIER, MD            
Sub-Investigator: MICHEL TULLIEZ, PROFESSOR            
Principal Investigator: CATHERINE CORDONNIER, MD            
CHU de Dijon Recruiting
Dijon, France, 21034
Contact: Denis CAILLOT     0033380293645        
Sub-Investigator: BERGER, MD            
Sub-Investigator: BASTIE, MD            
Sub-Investigator: CASANOVAS, MD            
Sub-Investigator: SOLARY, Professor            
CHU Albert Michallon Not yet recruiting
Grenoble, France, 38043
Contact: Jean-Yves CAHN, Professor     0033476769445     JYCahn@chu-grenoble.fr    
Principal Investigator: CAHN, Professor            
CHRU Hurriez Not yet recruiting
Lille, France, 59057
Contact: Bruno QUESNEL, Profesor     0033320446640     b-quesnel@chru.fr    
Principal Investigator: QUESNEL, Professor            
CHRU de Limoges Recruiting
Limoges, France, 87046
Contact: Dominique BORDESSOULE, Profesor     0033555056642     bordessoule@unilim.fr    
Principal Investigator: Dominique BORDESSOULE, Professor            
Sub-Investigator: Marie Pierre CHAURY, MD            
Hopital Edouard Herriot Not yet recruiting
Lyon, France, 69437
Contact: Youcef CHELGHOUM, MD     0033472117324     youcef-chelghoum@chu-lyon.fr    
Sub-Investigator: MICHALLET, Professor            
Sub-Investigator: TRONCY, MD            
Principal Investigator: CHELGHOUM, MD            
Hopital Saint Louis Recruiting
Paris, France, 75475
Contact: Hervé DOMBRET, Professor     33142499643     herve.dombret@sls.aphp.fr    
Principal Investigator: Hervé DOMBRET, Professor            
Sub-Investigator: Emmanuel RAFFOUX, MD            
CHU Brabois Recruiting
Vandoeuvre, France, 54511
Contact: Agnes GUERCI-BRESLER, MD     0033383153281     a.guerci@chu-nancy.fr    
Principal Investigator: GUERCI-BRESLER, MD            
Hopital Hotel Dieu Recruiting
Nantes, France, 44093
Contact: Jean-Luc HAROUSSEAU     0033240083271     jean-luc.harousseau@univ-nantes.fr    
Principal Investigator: HAROUSSEAU, Professor            
Hopital Archet Recruiting
Nice, France, 06202
Contact: Laurence LEGROS, MD     0033492035844     legros.l@chu-nice.fr    
Principal Investigator: LEGROS, MD            
Hopital Cochin Recruiting
Paris, France, 75679
Contact: Francois DREYFUS, Professor     003358412120     francois.dreyfus@cch.aphp.fr    
Principal Investigator: DREYFUS, Professor            
Hopital Saint Antoine Not yet recruiting
Paris, France, 75571
Contact: Francoise isnard, MD     00033149282622     francoise.isnard@sat.aphp.fr    
Principal Investigator: ISNARD, MD            
Sub-Investigator: FOUILLARD, MD            
Sub-Investigator: LEMONNIER, MD            
Sub-Investigator: LAPORTE, MD            
Sub-Investigator: GARDERET, MD            
Sub-Investigator: COPPO, MD            
Sub-Investigator: GORIN, Professor            
Hopital Jean-Bernard Recruiting
Poitiers, France, 86021
Contact: Francois GUILHOT, Professor     0033549444201     f.guilhot@chu-poitiers.fr    
Principal Investigator: GUILHOT, Profesor            
Sub-Investigator: ROY, MD            
CHRU de Reims Not yet recruiting
Reims, France, 51092
Contact: Chantal HIMBERLIN, MD     003326783644     chimberlin@chu-reims.fr    
Principal Investigator: HIMBERLIN, MD            
CHU Pontchaillou Recruiting
Rennes, France, 35033
Contact: Martine ESCOFFRE-BARBE     0033299284291     martine.escoffre-barbe@chu-rennes.fr    
Principal Investigator: ESCOFFRE-BARBE, MD            
Sub-Investigator: DAURIAC, MD            
Sub-Investigator: BERNARD, MD            
Sub-Investigator: LAMY, MD            
Sub-Investigator: NIMUBONA, MD            
Hopital Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Shanti AME, MD     0033388127680     shanti.ame@chru-strasbourg.fr    
Principal Investigator: AME, MD            
Hopital Purpan Recruiting
Toulouse, France, 31031
Contact: Guy LAURENT, Professor     0033561772078     laurent.g@chu-toulouse.fr    
Principal Investigator: LAURENT, Professor            
Principal Investigator: Odyle Beyne-Rauzy, MD            
Sub-Investigator: Christian RECHER, MD            
CH Versailles Recruiting
Versailles, France, 78000
Contact: Sylvie CASTAIGNE, MD     0033139638909     scastaigne@ch-versailles.fr    
Principal Investigator: CASTAIGNE, Professor            
Sub-Investigator: Anne Laure TAKSIN, MD            
Sub-Investigator: Philippe ROUSSELOT, MD            
Hopital Paoli Calmette Recruiting
Marseille, France, 13273
Contact: Norbert VEY, MD     0033431223695     veyn@marseille.fnclcc.fr    
Principal Investigator: VEY, MD            
Sub-Investigator: CHARBONNIER, MD            
Sub-Investigator: GASTAUT, Professor            
Sub-Investigator: BOUABDALLAH, MD            
Sub-Investigator: REY, MD            
Sub-Investigator: STOPPA, MD            
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Investigators
Principal Investigator: Claude GARDIN, MD Groupe Francophone des Myelodysplasies
  More Information

Study ID Numbers: GFM aza05
Study First Received: March 9, 2007
Last Updated: March 9, 2007
ClinicalTrials.gov Identifier: NCT00446303  
Health Authority: France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Myelodysplastic syndromes
Leukemia
Preleukemia
Precancerous Conditions
Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Azacitidine
Leukemia, Myeloid
Bone Marrow Diseases
Leukemia, Myeloid, Acute

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Pathologic Processes
Disease
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Syndrome
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009