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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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.
- Reponse duration and cumulative incidence of relapses [ Time Frame: 1-24 months ]
- Toxicity according to WHO [ Time Frame: 1-24 months ]
- Overall survival
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
|Principal Investigator:||Claude GARDIN, MD||Groupe Francophone des Myelodysplasies|