Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003436
Protocol/serial number
G8223452
Study information
Scientific title
Acronym
AML 12
Study hypothesis
To compare two induction schedules (ADE and MAE) with respect to achievement and duration of remission, survival, toxicity and supportive care requirements; to compare four versus five course of treatment in total (where the final course is either chemotherapy or BMT) with respect to remission duration, relapse rates, deaths in remission and overall survival, to compare the value of allogeneic BMT vs. conventional chemotherapy with respect to remission duration, relapse rates, death in remission and overall survival, to reduce toxicity without compromising survival by restricting the number of patients receiving BMT.
To evaluate the therapeutic relevance of morphological, cytogenetic, molecular-genetic and immunophenotype assessments, quality of life assessment and economic evaluation and monitoring cardiac function with observation at trial entry, prior to each antracycline/anthracenedione-containing course, prior to allograft and within 4 weeks of the end of therapy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Leukaemia
Intervention
ADE/MAE
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Achievement and duration of remission, survival, febrile incidents, toxicity including cardiotoxicity, supportive care requirements and long-term outcome.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1995
Overall trial end date
01/01/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. They have one of the types of acute myeloid leukaemia (de novo or secondary)
2. They have aggressive myelodysplastic syndrome (MDS) (Refractory anemia with excess blasts [RAEB], Refractory anemia with excess blasts in transformation [RAEB-t]) for whom AML-type therapy is considered appropriate
3. They are considered suitable for intensive chemotherapy
4. They are under 16 years and if the patients/parents have given informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2,000
Participant exclusion criteria
1. Patients who have previously received cytotoxic chemotherapy for leukaemia;
2. They are in blast transformation of chronic myeloid leukaemia;
3. They have a concurrent active malignancy or the physician and patient/parents consider that intensive therapy is not an appropriate option.
Recruitment start date
01/04/1995
Recruitment end date
01/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Haematology
Glasgow
G3 8SJ
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16304572
Publication citations
-
Results
Gibson BE, Wheatley K, Hann IM, Stevens RF, Webb D, Hills RK, De Graaf SS, Harrison CJ, Treatment strategy and long-term results in paediatric patients treated in consecutive UK AML trials., Leukemia, 2005, 19, 12, 2130-2138, doi: 10.1038/sj.leu.2403924.