Multicenter Randomised Clinical Trial in Acute Myeloid Leukemia Treatment Based on Three Anthracyclines, Comparing Two Types of Consolidation With Different ARA-C Doses Followed by One Year Maintenance
15 Years
60 Years
Both
Acute Myeloid Leukemia
Trial Information
Multicenter Randomised Clinical Trial in Acute Myeloid Leukemia Treatment Based on Three Anthracyclines, Comparing Two Types of Consolidation With Different ARA-C Doses Followed by One Year Maintenance
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
5 years
Safety Issue:
Yes
Principal Investigator
Valeriy G Savchenko
Investigator Role:
Study Director
Investigator Affiliation:
National Research center of Hematology
Authority:
Russia: Ministry of Health of the Russian Federation
Study ID:
AML-01.10
NCT ID:
NCT01587430
Start Date:
January 2010
Completion Date:
January 2015
Related Keywords:
- Acute Myeloid Leukemia
- acute myeloid leukemia
- anthracyclines
- high dose cytarabine
- maintenance
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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