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ISRCTN
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ISRCTN95257778
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DOI
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10.1186/ISRCTN95257778
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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UKALL R2 - Acute Lymphoblastic Leukaemia trial
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Scientific title
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Acronym
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UKALL R2
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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 continuing chemotherapy with unrelated donor BMT in relapsed childhood ALL following a common re-induction and consolidation regimen.
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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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Acute Lymphoblastic Leukaemia
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Participants - inclusion criteria
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They are children under 15 years at original diagnosis and treated on UKALL trials or pilot studies with first relapse less than 4 years from the start of treatment of ALL at any site and no suitable related bone marrow treatment (BMT) donor is available
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Participants - exclusion criteria
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1. They are multiply relapsed patients
2. They have a prior history of toxicity or organ damage such that completion of the protocol is felt unlikely at the outset
3. They have had an isolated CNS or testicular relapse more than 6 months off treatment.
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Anticipated start date
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01/02/1995
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Anticipated end date
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30/09/2008
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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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200 - Closed to recruitment - in long term follow-up
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Interventions
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Continuing chemotherapy/unrelated donor BMT
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Primary outcome measure(s)
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Survival, disease free survival
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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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UK Medical Research Council
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15982346
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Contact name
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Dr
PJ
Darbyshire
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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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06/04/2000
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Last edited
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04/10/2007
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Date ISRCTN assigned
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06/04/2000
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