Acute Myeloid Leukemia
Conditions
Keywords
acute myeloid leukemia, anthracyclines, high dose cytarabine, maintenance
Brief summary
The goal: to evaluate the role of high dose ara-c plus idarubicin and mitoxantrone consolidation followed by maintenance in the setting of high total cumulative anthracyclines dose(720-660 mg/m2).
Detailed description
In previous Russian AML multicenter studies it was shown that escalation of ARA-C dose (from 5,6 g to 72 g in 4 induction/consolidation courses) in parallel with anthracyclines dose reduction (from 630 mg/m2 to 285 mg/m2)did not improve survival, but decreased feasibility. In the ongoing trial we try to learn whether anthracyclines dose escalation (up to 720-660 mg m2) will or will not equivalise the standard (5,6 g in 4 induction/consolidation courses) and high (14,8 g) ARA-C doses.
Interventions
DRUGhigh dose ARA-C
high dose ARA-C consolidation together with high cumulative dose of anthracyclines daunorubicin, idarubicin, mitoxantrone(720-660 mg/m2)
DRUGstandard dose ARA-C
Sponsors
National Research Center for Hematology, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* de novo acute myeloid leukemia - age 15-60
Exclusion criteria
* secondary acute myeloid leukemia * acute myeloid leukemia from myelodysplastic syndrome * Ph+ acute myeloid leukemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 5 years |
Countries
Russia
Outcome results
None listed