NCT00446303

A Phase II Study of Maintenance With Azacitidine in MDS Patients

A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

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

Conditions

• Leukemia, Myelocytic, Acute
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2007-03-12
• Last updated: 2012-01-19

Locations

25 sites across 1 country: France