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AML 12 - Acute myeloid leukaemia Adults (modified)
ISRCTN ISRCTN17833622
DOI 10.1186/ISRCTN17833622
ClinicalTrials.gov identifier
EudraCT number
Public title AML 12 - Acute myeloid leukaemia Adults (modified)
Scientific title
Acronym AML 12
Serial number at source G8223452
Study hypothesis To improve the outcome of patients with newly diagnosed AML by randomised evaluation of:

1. Standard dose (100 mg/m2 b.d.) versus higher dose (200mg/m2 b.d.) Ara-C within a DAT (daunorubicin, Ara-C, thioguanine) induction regimen (courses 1 and 2)
2. The addition of retinoic acid (ATRA) during and after induction chemotherapy (courses 1 and 2)
3. Four versus five courses of therapy in total (where the final course is either chemotherapy or transplant)
4. Bone marrow transplantation (BMT) (either allogenic or autologous) versus conventional chemotherapy as the final course (good risk patients should not be entered into this randomisation).

The therapeutic relevance of morphology, cytogenetics, molecular genetics and immunophenotype will also be investigated.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Leukaemia
Participants - inclusion criteria 1. Acute myeloid leukaemia (AML) (any type of de novo or secondary AML, including acute promyelocytic leukemia [APL])
2. Suitable for intensive therapy
3. Normally under the age of 60 years (but older patients can be entered if considered suitable)
4. Informed consent given
Participants - exclusion criteria 1. Previous cytotoxic therapy for leukaemia
2. Concurrent active malignancy
3. Blast transformation of CML
4. Pregnant or lactating
5. Intensive chemotherapy not considered to be an appropriate treatment option
6. Patients with APL are not eligible for the ATRA randomisation
Anticipated start date 01/10/1994
Anticipated end date 01/01/2001
Status of trial Completed
Patient information material
Target number of participants Not provided at time of registration
Interventions Four randomised comparisons:
1. S-DAT versus H-DAT
2. All-trans retinoic acid (ATRA) versus control
3. 4 versus 5 courses of therapy in total
4. Bone Marrow Transplant (BMT) versus chemotherapy as the final course
Primary outcome measure(s) Survival; complete remission (CR) rates and reason for failure; duration of remission; toxicity; quality of life; supportive care requirements.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Medical Research Council (MRC) (UK)
Trial website
Publications 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11535508
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16076872
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19965647
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23439754
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24855211
Contact name Prof  AK  Burnett
  Address Department of Haematology
University of Wales College of Medicine
Heath Park
  City/town Cardiff
  Zip/Postcode CF14 4XN
  Country United Kingdom
  Tel +44 (0)29 2074 2375
  Fax +44 (0)29 2074 4655
  Email burnettak@cardiff.ac.uk
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 25/10/2000
Last edited 26/09/2014
Date ISRCTN assigned 25/10/2000
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