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ISRCTN
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ISRCTN64649191
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DOI
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10.1186/ISRCTN64649191
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ClinicalTrials.gov identifier
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NCT00003436
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EudraCT number
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Public title
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Acute myeloid leukaemia (AML) trial 12 (protocol for children)
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Scientific title
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Acronym
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AML 12
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Serial number at source
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G8223452
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Leukaemia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/04/1995
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Anticipated end date
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01/01/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2,000
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Interventions
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ADE/MAE
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Primary outcome measure(s)
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Achievement and duration of remission, survival, febrile incidents, toxicity including cardiotoxicity, supportive care requirements and long-term outcome.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16304572
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Contact name
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Dr
BEG
Gibson
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Address
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Department of Haematology
Royal Hospital for Sick Children
Yorkhill
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City/town
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Glasgow
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Zip/Postcode
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G3 8SJ
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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14/01/2009
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Date ISRCTN assigned
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25/10/2000
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