CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS
Conditions
Brief summary
The primary endpoint is Overall Survival by 2 years
Detailed description
Adverse events - CTCAE Version 4.0, Cumulative rate of patients achieving CHR, Cumulative rate of patients achieving complete cytogenetic responses, Cumulative rate of patients achieving molecular responses, Cumulative rate of patients reverting to chronic phase CML, Analysis of clonal architecture, methylation profile, bcr-abl mutations and cytogenetics in blast crisis and AP at baseline, and in case of relapse or failure, Event free survival, duration of response, Number of patients allocated to allogenic transplant, Survival after transplant and post-transplantation relapse rate
Interventions
DRUGAZACITIDINE ARROW 25 mg/mL
DRUGpoudre pour suspension injectable
Sponsors
Centre Hospitalier De Versailles
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is Overall Survival by 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events - CTCAE Version 4.0, Cumulative rate of patients achieving CHR, Cumulative rate of patients achieving complete cytogenetic responses, Cumulative rate of patients achieving molecular responses, Cumulative rate of patients reverting to chronic phase CML, Analysis of clonal architecture, methylation profile, bcr-abl mutations and cytogenetics in blast crisis and AP at baseline, and in case of relapse or failure, Event free survival, duration of response, Number of patients allocated to allogenic transplant, Survival after transplant and post-transplantation relapse rate | — |
Countries
France
Outcome results
None listed