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TRIAL Relapsed AML 2001/01: a randomised phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukaemia (AML)
ISRCTN ISRCTN94206677
DOI 10.1186/ISRCTN94206677
ClinicalTrials.gov identifier
EudraCT number
Public title TRIAL Relapsed AML 2001/01: a randomised phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukaemia (AML)
Scientific title
Acronym Relapsed AML 2001/01
Serial number at source NTR136
Study hypothesis Addition of liposomal daunorubicin (DaunoXome®) to fludarabine, ara-C and granulocyte colony-stimulating factor (G-CSF) (FLAG) in the first reinduction course will result in improved treatment response with acceptable toxicity and without increased cardiotoxicity.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the local medical ethics committee
Study design Multicentre, randomised, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Acute myeloid leukaemia
Participants - inclusion criteria 1. Primary refractory acutye myeloid leukaemia (AML)
2. First relapsed AML
3. Second or subsequent relapsed AML, but not previously treated according to protocol Relapsed AML 2001/01
4. Below 18 years of age at initial diagnosis
5. Signed informed consent
Participants - exclusion criteria 1. Symptomatic cardiac dysfunction (CTC grade 3 or 4), and/or a fractional shortening at echocardiography below 29%
2. Karnofsky performance status less than 40% (children aged 16 years and older) or Lansky performance status of less than 40% (younger children)
3. Any other organ dysfunction (CTC grade 4) that will interfere with the protocol treatment
4. Inability to apply to the protocol for other reasons
5. AML FAB type M3, acute promyelocytic leukaemia, and/or t(1517) and/or PML-RARalfa fusion gene
Anticipated start date 11/01/2001
Anticipated end date 11/01/2007
Status of trial Completed
Patient information material
Target number of participants 400
Interventions Addition of liposomal daunorubicin (DaunoXome®) to FLAG in reinduction course I.
Primary outcome measure(s) Percentage of BM blasts greater than 20% after course I, determined 4 - 6 weeks after the start.
Secondary outcome measure(s) 1. Toxicity, focusing on but not limited to bone marrow aplasia, mucosal toxicity and cardiotoxicity
2. Efficacy as determined by day 14 BM blasts, time to PB clearance of blasts, CR rate after two courses of chemotherapy, % of patients that underwent SCT, overall survival, event-free survival and disease-free survival
3. Clinical and cell biological features, and overall outcome of the entire cohort of patients with relapsed AML that has been registered in the time period of patient accrual (also including patients that were not treated according to this protocol)
Sources of funding Not provided at time of registration
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23319696
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24763401
Contact name Dr  Gertjan J.L.  Kaspers
  Address Pediatric Oncology/Hematology
Vrije University Medical Center
De Boelelaan 1117
  City/town Amsterdam
  Zip/Postcode 1081 HV
  Country Netherlands
  Tel +31 (0)20 4442420
  Fax +31 (0)20 4442422
  Email gjl.kaspers@vumc.nl
Sponsor Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands)
  Address Leyweg 299
  City/town Amsterdam
  Zip/Postcode 2545 CJ
  Country Netherlands
  Tel +31 (0)70 367 4545
  Fax +31 (0)70 367 0868
  Email info@skion.nl
  Sponsor website: http://www.skion.nl/
Date applied 20/12/2005
Last edited 28/04/2014
Date ISRCTN assigned 20/12/2005
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