Back to results3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Unknown status
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
high dose ARA-C
standard dose ARA-C
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia, anthracyclines, high dose cytarabine, maintenance
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
Sites / Locations
- National Research Center for Hematology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
high dose ARA-C
standard dose ARA-C
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT01587430
First Posted
April 26, 2012
Last Updated
April 4, 2014
Sponsor
National Research Center for Hematology, Russia
1. Study Identification
Unique Protocol Identification Number
NCT01587430
Brief Title
3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Center for Hematology, Russia
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
acute myeloid leukemia, anthracyclines, high dose cytarabine, maintenance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high dose ARA-C
Arm Type
Active Comparator
Arm Description
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)
Arm Title
standard dose ARA-C
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
high dose ARA-C
Intervention Description
high dose ARA-C consolidation together with high cumulative dose of anthracyclines daunorubicin, idarubicin, mitoxantrone(720-660 mg/m2)
Intervention Type
Drug
Intervention Name(s)
standard dose ARA-C
Other Intervention Name(s)
standard dose ARA-C consolidation together with high cumulative dose of anthracyclines daunorubicin, idarubicin, mitoxantrone(720-660 mg/m2)
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valeriy G Savchenko
Organizational Affiliation
National Research center of Hematology
Official's Role
Study Director
Facility Information:
Facility Name
National Research Center for Hematology
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
25314773
Citation
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.
Results Reference
derived
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3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia
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