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

NCT01587430 | Unknown Phase 4 DMC

• 1 other identifier: AML-01.10
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemia; anthracyclines; high dose cytarabine; maintenance

Outcome Measures

Primary Outcomes (1)

• overall survival

  5 years

Study Arms (2)

high dose ARA-C

ACTIVE COMPARATOR

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

standard dose ARA-C

ACTIVE COMPARATOR

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

Interventions

high dose ARA-C DRUG

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

high dose ARA-C

standard dose ARA-C DRUG

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

standard dose ARA-C

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• de novo acute myeloid leukemia - age 15-60

You may not qualify if:

• secondary acute myeloid leukemia
• acute myeloid leukemia from myelodysplastic syndrome
• Ph+ acute myeloid leukemia

Sponsors & Collaborators

• National Research Center for Hematology, Russia: lead

Study Sites (1)

National Research Center for Hematology

Moscow, 125167, Russia

Location

Related Publications (1)

• 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.

  PMID: 25314773 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; Idarubicin; Mitoxantrone

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Anthraquinones; Anthrones; Anthracenes; Quinones

Study Officials

• Valeriy G Savchenko

  National Research center of Hematology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

RU (1)