NCT01587430

3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 245 (estimated)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 15 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	high dose ARA-C	high dose ARA-C consolidation together with high cumulative dose of anthracyclines daunorubicin, idarubicin, mitoxantrone(720-660 mg/m2)
DRUG	standard dose ARA-C

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-04-01
• Completion: 2015-01-01
• First posted: 2012-04-30
• Last updated: 2014-04-07

Locations

1 site across 1 country: Russia