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

NCT ID: NCT01587430

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-01-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

high dose ARA-C

Intervention Type: DRUG

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

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)

Group Type: ACTIVE_COMPARATOR

standard dose ARA-C

Intervention Type: DRUG

Interventions

high dose ARA-C

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

Intervention Type: DRUG

standard dose ARA-C

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Center for Hematology, Russia

NETWORK

Sponsor Role: lead

Responsible Party

Elena N.Parovichnikova

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valeriy G Savchenko

Role: STUDY_DIRECTOR

National Research center of Hematology

Locations

National Research Center for Hematology

Moscow, , Russia

Countries

Russia

References

Parovichnikova EN, Troitskaia VV, Kliasova GA, Kuz'mina LA, Sokolov AN, Paramonova EV, Galstian GM, Kessel'man SA, Drokov MIu, Vasil'eva VA, Obukhova TN, Kulikov SM, Savchenko VG. [Treating patients with acute myeloid leukemias (AML) according to the protocol of the AML-01.10 Russian multicenter randomized trial: the coordinating center's results]. Ter Arkh. 2014;86(7):14-23. Russian.

Reference Type: DERIVED

PMID: 25314773 (View on PubMed)

Other Identifiers

AML-01.10

Identifier Type: -

Identifier Source: org_study_id