| Title |
A Phase 3 Trial of Systematic Versus Response-Adapted Timed-Sequential Induction in Patients With Core Binding Factor (CBF) Acute Myeloid Leukemia (AML) |
| Scientific Title |
Core binding factor (CBF) acute myeloid leukemias (AML) include AMLs carrying the t(8;21) translocation as well as AMLs carrying either the inversion of chromosome 16 or translocation t(16;16). CBF-AMLs are characterized by their high sensitivity to standard chemotherapeutical agents, especially to cytarabine when administered as high-dose bolus infusions, and thus by a relative good prognosis. However, relapse rates are still comprised between 30 and 50% in these patients, even if overall survival may reach approximately 65% due to the potential salvage of late relapses. The primary purpose of the protocol is to compare two modalities of timed-sequential induction in order to improve the results of the treatment of CBF-AML patients. This protocol also includes the biological characterization of the heterogeneity of these diseases (gene mutation and transcription profiles), as well as a centralized minimal residual disease monitoring and centralized evaluation of pharmacogenetic polymorphisms. |
| Short Title |
Timed-Sequential Induction in CBF-AML |
| Trialgroup |
NN |
| Type of Trial |
randomized, open-label |
| Disease |
Acute myeloic leukemia(AML) AML all subtypes without FAB M3
|
| Age |
18-60 years |
| Status |
Active |
| Start of Recruitment |
29.01.2007 |
| Shortprotocol |
Shortprotocol |
| Remark |
contacts see: http://clinicaltrials.gov/ct2/show/NCT00428558 |
created 