High-dose Cytarabine and Survival in AML

Acute Myeloid Leukemia Clinical Trial

Official title:

Role of Consolidation With High-dose Cytarabine in Overall Survival of Adults With Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034839
• Other study ID #: mcazevedo01
• Status: Completed
• Phase: N/A
• First received: December 16, 2009
• Last updated: December 16, 2009
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 92 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5 years	No