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

Sponsor

National Research Center for Hematology, Russia (Other)

Overall Status

Unknown status

CT.gov ID

NCT01587430

Collaborator

(none)

245

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: high dose ARA-C Drug: standard dose ARA-C	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

245 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: high dose ARA-C High dose ARA-C will be applied after two 7+3 induction courses during the first and the second consolidation courses: ARA-C 1 g/m2 bid 1-3 days with idarubicin (8mg/m2 3-5 days)and mitoxantrone (10 mg/m2 3-5 days)	Drug: high dose ARA-C high dose ARA-C consolidation together with high cumulative dose of anthracyclines daunorubicin, idarubicin, mitoxantrone(720-660 mg/m2)
Active Comparator: standard dose ARA-C Standard dose ARA-C will be applied after two 7+3 induction courses the first and the second consolidation courses : ARA-C 100 g/m2 bid 1-7 days with idarubicin (8mg/m2 1-3 days)and mitoxantrone (10 mg/m2 1-3 days)	Drug: standard dose ARA-C Other Names: standard dose ARA-C consolidation together with high cumulative dose of anthracyclines daunorubicin, idarubicin, mitoxantrone(720-660 mg/m2)

Arm

Intervention/Treatment

Active Comparator: high dose ARA-C

High dose ARA-C will be applied after two 7+3 induction courses during the first and the second consolidation courses: ARA-C 1 g/m2 bid 1-3 days with idarubicin (8mg/m2 3-5 days)and mitoxantrone (10 mg/m2 3-5 days)

Drug: high dose ARA-C

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

Active Comparator: standard dose ARA-C

Standard dose ARA-C will be applied after two 7+3 induction courses the first and the second consolidation courses : ARA-C 100 g/m2 bid 1-7 days with idarubicin (8mg/m2 1-3 days)and mitoxantrone (10 mg/m2 1-3 days)

Drug: standard dose ARA-C

Other Names:

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