- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034839
High-dose Cytarabine and Survival in AML
Role of Consolidation With High-dose Cytarabine in Overall Survival of Adults With Acute Myeloid Leukemia
Study Overview
Status
Conditions
Detailed Description
Background In adults with acute myeloid leukemia, especially those < 60 years of age, high-dose cytarabine consolidation therapy has been shown to influence survival. However, the appropriate dose has not been defined. We evaluated survival after cytarabine consolidation therapy at three different doses.
Design and Methods We conducted a single-center, retrospective study involving 499 acute myeloid leukemia patients, aged 18-92 years, all evaluated between 1978 and 2007. Of those 499 patients, 400 received curative treatment and 203 received cytarabine consolidation. The latter were divided into three groups: low-dose (receiving < 1.5 g/m2 of i.v. cytarabine, every 12 h, on 3 alternate days, for up to 4 cycles); medium-high-dose (< 45.45 g-the median dose-by the end of the cycles); and very-high-dose (≥ 45.45 g by the end of the cycles).
Results Among the 400 patients receiving curative treatment, five-year survival was 22.8% (91 patients). Cytarabine consolidation dose was an independent determinant of survival (significant differences were found among the groups), whereas age, karyotype, induction protocol, French-American-British classification and etiology were not. In comparison with the very-high-dose group, the risk of death was 3.871 times (95% CI, 1.043 to 14.370 times) higher in the high-dose group (p=0.043) and 9.775 times (95% CI, 2.493 to 38.320 times) higher in the low-dose group (p=0.001), assuming, in both cases, that age, karyotype, French-American-British classification and etiology of acute myeloid leukemia were constant.
Conclusions Consolidation therapy with high-dose cytarabine appears to improve survival in patients with acute myeloid leukemia.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 05430010
- University of Sao Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- clinical diagnosis of acute myeloid leukemia
- age 18 years or above
- must have been treated with potentially curative therapy
Exclusion Criteria:
- children or age less than 18 years
- palliative therapy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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acute myeloid leukemia, adults
Adults treated for acute myeloid leukemia in our hospital between 1978 and 2007
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Investigators
- Study Director: Pedro ED Llacer, MD, PhD, University of Sao Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- mcazevedo01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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