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ISRCTN
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ISRCTN16757172
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DOI
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10.1186/ISRCTN16757172
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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UKALL XI (92) - Acute lymphoblastic leukaemia trial
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Scientific title
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Acronym
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UKALL XI (92)
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Serial number at source
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G8223452
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Study hypothesis
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To test if CNS disease eradication can be successfully achieved without cranial radiotherapy by using CNS directed chemotherapy, to determine whether the use of high-dose intravenous MTX as part of the CNS therapy will reduce the incidence of systematic relapse, to assess whether a third intensification block of chemotherapy effects disease free survival, to compare by psychometric testing the long term learning and neuropsychological effects of the different CNS treatments.
Please note that the target number of participants was added as of 18/07/2007.
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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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They are children including those with Down's syndrome or leukaemia associated chromosome translocations over 1 year and under 15 years with newly diagnosed ALL of any immunologic subtype except B-ALL
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Participants - exclusion criteria
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Children with B-ALL and those under 1 year
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Anticipated start date
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01/01/1990
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Anticipated end date
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31/12/1997
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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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2,090 children were recruited
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Interventions
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Central Nervous System (CNS) directed chemotherapy/control
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Primary outcome measure(s)
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Disease-free survival, CNS disease eradication, relapse rates, psychometric test results.
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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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Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/11328289
2. http://www.ncbi.nlm.nih.gov/pubmed/14675406
3. http://www.ncbi.nlm.nih.gov/pubmed/11813173
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Contact name
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Dr
F
Hill
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Address
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The Children's Hospital
Ladywood Middleway
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City/town
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Birmingham
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Zip/Postcode
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B16 8ET
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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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31/03/2009
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Date ISRCTN assigned
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25/10/2000
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