A Phase II Study of Maintenance With Azacitidine in MDS Patients
1 other identifier
interventional
39
1 country
25
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2006
Typical duration for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 9, 2007
CompletedFirst Posted
Study publicly available on registry
March 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJanuary 19, 2012
June 1, 2010
4 years
March 9, 2007
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reponse duration and cumulative incidence of relapses
1-24 months
Secondary Outcomes (2)
Toxicity according to WHO
1-24 months
Overall survival
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Groupe Francophone des Myelodysplasieslead
- Celgene Corporationcollaborator
Study Sites (25)
CHU d'Amiens
Amiens, 80054, France
CHU Angers
Angers, 49033, France
CH d'Avignon
Avignon, 84000, France
CHU de Caen
Caen, 14033, France
Hopital d'Instruction des Armées Percy
Clamart, 92140, France
Hopital Henri Mondor
Créteil, 94000, France
CHU de Dijon
Dijon, 21034, France
CHU Albert Michallon
Grenoble, 38043, France
CHRU Hurriez
Lille, 59057, France
CHRU de Limoges
Limoges, 87046, France
Hopital Edouard Herriot
Lyon, 69437, France
Hopital Paoli Calmette
Marseille, 13273, France
Hopital Hotel Dieu
Nantes, 44093, France
Hopital Archet
Nice, 06202, France
Hopital Saint Louis
Paris, 75475, France
Hopital Saint Antoine
Paris, 75571, France
Hopital Cochin
Paris, 75679, France
Hopital Haut Leveque
Pessac, 33604, France
Hopital Jean-Bernard
Poitiers, 86021, France
CHRU de Reims
Reims, 51092, France
CHU Pontchaillou
Rennes, 35033, France
Hopital Hautepierre
Strasbourg, 67098, France
Hopital Purpan
Toulouse, 31031, France
CHU Brabois
Vandœuvre-lès-Nancy, 54511, France
CH Versailles
Versailles, 78000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claude GARDIN, MD
Groupe Francophone des Myelodysplasies
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2007
First Posted
March 12, 2007
Study Start
July 1, 2006
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
January 19, 2012
Record last verified: 2010-06