Secondary Acute Myeloid Leukemia (AML) Clinical Trial
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)
This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00531232 -
A Dose Confirmation Study of Oral Clofarabine for Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)
|
Phase 2 |