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ISRCTN
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ISRCTN16757172
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ClinicalTrials.gov identifier
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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.
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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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Added as of 18/07/2007: 2090 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: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11328289
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14675406
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=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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12/09/2007
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Date ISRCTN assigned
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25/10/2000
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