High-dose Cytarabine and Survival in AML

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT01034839
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

In adults with acute myeloid leukemia, especially those \< 60 years of age, high-dose cytarabine consolidation therapy has been shown to influence survival, but the appropriate dose has not been defined.

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 Timeline

• Study Start: 2006-01
• Primary Completion: 2008-12
• Status Verified: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Last Update Submitted: 2009-12-16
• Study First Posted: 2009-12-18
• Last Update Posted: 2009-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil