Clinical trial NCT01034839: High-dose Cytarabine and Survival in AML
Official title: Role of Consolidation With High-dose Cytarabine in Overall Survival of Adults With Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
prognosis
cytarabine
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute myeloid leukemia in adults treated in the University of Sao Paulo between 1978 and 2007

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Pedro ED Llacer, MD, PhD
role: STUDY_DIRECTOR
References: