A Remission Induction Therapy and Risk-oriented Postremission Strategy for Adult Acute Myelogenous Leukemia (AML)
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
The study was set up to assess:
1. Standard-dose versus high-dose remission induction therapy. A standard ICE chemotherapy
vs sequential high-dose cytarabine, with appropriate supportive/prophylactic measures,
followed by morphological, cytogenetic and molecular monitoring of remission.
2. A risk-oriented postremission therapy: HR patients will be electively submitted to
allogeneic stem cell transplantation (allo-SCT), whenever possible (related/unrelated
donor/cord blood; ablative/non-ablative conditioning according to national and local
protocols and guidelines). Provided sufficient blood stem cells were previously
collected (>2x10e6/kg Cluster of Differentiation 34 cells), SR patients and HR patients
excluded from allo-SCT and aged 65 years or less will be randomized to: myeloablative
autologous blood stem cell transplantation vs non-myeloablative, multicycle, autologous
blood stem cell-supported high-dose cytarabine-based therapy.
- HR/SR patients unable to be randomized because of inadequate blood stem cell yield
will receive intermediate-dose consolidation; patients aged >65 years will be
treated with age-adapted therapy.