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. 2015 Jun 3;2015(6):CD010432. doi: 10.1002/14651858.CD010432.pub2

Creutzig 2013.

Methods Design:

  • RCT with two arms: IDA versus L‐DNR


Recruitment period:

  • March 2004 to April 2010


Median follow‐up:

  • 60 months (range: 6 months to 102 months)
Participants Eligibility criteria:
Inclusion criteria:

  • < 18 years

  • AML


Exclusion criteria:

  • Down's syndrome


Patients randomised (n = 521):

  • IDA arm: n = 264

  • L‐DNR arm: n = 257


Median age:

  • IDA arm: 8 years (range: 2 to 14 years)

  • L‐DNR arm: 10 years (range: 2 to 15 years)


Gender (male, female):

  • IDA arm: n = 133, n = 131

  • L‐DNR arm: n = 135, n = 122


Country:

  • Germany, Austria, Switzerland, and the Czech Republic
Interventions IDA arm: IAE regimen, 1 cycle

  • IDA: 12 mg/m²/d for 3 days, IV

  • Ara‐C: not stated

  • VP‐16: not stated


L‐DNR arm: L‐DAE regimen, 1 cycle

  • L‐DNR: 80 mg/m²/d for 3 days, IV

  • Ara‐C: not stated

  • VP‐16: not stated
Outcomes Outcomes and time‐points from the study that are considered in the review:

  • reported: OS, CR, death on induction therapy, relapse, AEs

  • not reported: DFS, quality of life
Notes Published as a journal article
Funded by Deutsche Krebshilfe e.V. and University Hospital Motol, Prague, Czech Republic
Dirk Reinhardt is a member of the advisory board from Galen. All other authors declared no conflict of interest
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "521 were randomized"
Comment: the study probably had an adequate sequence generation
Allocation concealment (selection bias) Unclear risk No information provided
Blinding (performance bias and detection bias) 
 Overall survival Low risk Comment: the review authors judge that the outcome OS is unlikely to be influenced by lack of blinding.
Blinding (performance bias and detection bias) 
 All other outcomes High risk Comment: blinding was not explicitly stated
Incomplete outcome data (attrition bias) 
 OS and DFS Low risk Comment: all randomised patients were included in the analyses
Selective reporting (reporting bias) Unclear risk Comment: the study has no registered study protocol. The review authors have no information to permit judgement
Other bias Unclear risk No information provided