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Trial record 87 of 253 for:    IDARUBICIN

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

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ClinicalTrials.gov Identifier: NCT01587430
Recruitment Status : Unknown
Verified April 2014 by Elena N.Parovichnikova, National Research Center for Hematology, Russia.
Recruitment status was:  Active, not recruiting
First Posted : April 30, 2012
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Elena N.Parovichnikova, National Research Center for Hematology, Russia

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 Type : Interventional  (Clinical Trial)
Estimated 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 : January 2010
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : January 2015


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




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]


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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587430


Locations
Russian Federation
National Research Center for Hematology
Moscow, Russian Federation, 125167
Sponsors and Collaborators
National Research Center for Hematology, Russia
Investigators
Study Director: Valeriy G Savchenko National Research center of Hematology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elena N.Parovichnikova, MD PhD, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT01587430     History of Changes
Other Study ID Numbers: AML-01.10
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Keywords provided by Elena N.Parovichnikova, National Research Center for Hematology, Russia:
acute myeloid leukemia
anthracyclines
high dose cytarabine
maintenance

Additional relevant MeSH terms:
Idarubicin
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Mitoxantrone
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic