Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T
Recruitment status was: Active, not recruiting
|De Novo Akute Myeloid Leukemia (AML) Secondary Acute Myeloid Leukemia (AML) Refractory Anemia With Excess of Blasts in Transformation||Drug: Cytarabine Drug: Idarubicin Drug: Etoposide Drug: Fludarabine Drug: G-CSF Drug: Daunorubicine||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Protocol for the Treatment of Adults Aged </= 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial)|
- Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.
- Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients.
- Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR.
- Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease.
|Study Start Date:||January 1999|
|Estimated Study Completion Date:||September 2005|
Assessment of the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with bad response to the first induction cycle and/or with a high risk karyotype.
Optimization of the late consolidation therapy in standard risk patients (SR) by a prospective randomized trial comparing a high-dose cytarabine/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy with an autologous peripheral blood stem cell transplantation (PBSCT)
Assessment of the antileukemic activity of the different treatment elements by monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR
Assessment of the prognostic relevance of minimal residual disease by quantification of the residual leukemic burden in haematological remission by Real-time PCR during follow-up
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209833
|Hannover Medical School|
|Hannover, Germany, 30625|
|Principal Investigator:||Arnold Ganser, Prof. Dr.||Hannover Medical School|