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ISRCTN
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ISRCTN26727615
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DOI
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10.1186/ISRCTN26727615
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ClinicalTrials.gov identifier
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NCT00003437
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EudraCT number
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Public title
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MRC ALL 97 - UK national lymphoblastic leukaemia (ALL) trial
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Scientific title
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Acronym
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MRC ALL 97
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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, in a randomised fashion the effect on remission rate, event-free survival and overall survival of i) receiving, both during induction and continuing treatment, either oral prednisolone or dexamethasone, ii) receiving, where appropriate and throughout treatment (apart from intensive blocks) either oral 6-mercaptopurine or 6-thioguanine. To assess the effect on event-free survival for all patients of a schedule concentrating on tight control of maintenance therapy. To collect data on i) thiopurine metabolites on serial blood samples to assess the adequacy of therapy and to compare the pharmacokinetics of 6-MP and 6-TG, and ii) the presence or absence of minimal residual disease in serial bone marrow samples to assess its clinical importance. Also, two randomisations will be carried forward from the previous trial (UKALL XI) until sufficient numbers have accrued to answer the questions to which they relate, so subsidiary objectives are i) to continue to study, in a prospective randomised manner, the effect of either two or three blocks of intensive therapy, and ii) to continue to study the effect of high-dose methotrexate or cranial irradiation for patients with presenting white counts in excess of 50 x 10^9/l.
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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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Open to all children with ALL except those in 'Exclusions'
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Participants - exclusion criteria
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1. Patients under 1 year or over 18 years,
2. B-ALL, Ph positivity, near haploidy in blasts or rearrangements involving the MLL gene on 11q23 and
3. High risk by Oxford Hazard Score (based on a function of age, gender and diagnostic leucocyte count)
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Anticipated start date
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01/01/1997
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Anticipated end date
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30/06/2002
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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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1800
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Interventions
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Oral prednisolone/dexamethasone/Oral 6-mercaptopurine/6-thioguanine
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Primary outcome measure(s)
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1. Disease-free survival
2. CNS disease eradication
3. Relapse rates
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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 (MRC) (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/15801953
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Contact name
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Dr
C
Mitchell
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Address
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Consultant Paediatric Oncologist
John Radcliffe Hospital
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DV
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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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13/08/2009
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Date ISRCTN assigned
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25/10/2000
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