High-dose Cytarabine and Survival in AML

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01034839
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition
Acute Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Role of Consolidation With High-dose Cytarabine in Overall Survival of Adults With Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 499
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
acute myeloid leukemia, adults
Adults treated for acute myeloid leukemia in our hospital between 1978 and 2007

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

Ages Eligible for Study:   18 Years to 92 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute myeloid leukemia in adults treated in the University of Sao Paulo between 1978 and 2007

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01034839

Locations
Brazil
University of Sao Paulo
Sao Paulo, Brazil, 05430010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Director: Pedro ED Llacer, MD, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Murilo Chermont Azevedo, University of Sao Paulo, General Hospital
ClinicalTrials.gov Identifier: NCT01034839     History of Changes
Other Study ID Numbers: mcazevedo01
Study First Received: December 16, 2009
Last Updated: December 16, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
acute myeloid leukemia
prognosis
cytarabine

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014