3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia
This trial is active, not recruiting.
|Condition||acute myeloid leukemia|
|Treatments||high dose ara-c, standard dose ara-c|
|Sponsor||National Research Center for Hematology, Russia|
|Start date||January 2010|
|End date||April 2014|
|Trial size||245 participants|
|Trial identifier||NCT01587430, AML-01.10|
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).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 5 years
Male or female participants from 15 years up to 60 years old.
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
|Official title||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|
|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.|
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