Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003437
Protocol/serial number
G8223452
Study information
Scientific title
Acronym
MRC ALL 97
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Leukaemia
Intervention
Oral prednisolone/dexamethasone/Oral 6-mercaptopurine/6-thioguanine
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Disease-free survival
2. CNS disease eradication
3. Relapse rates
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1997
Overall trial end date
30/06/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Open to all children with ALL except those in 'Exclusions'
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
1800
Participant exclusion criteria
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)
Recruitment start date
01/01/1997
Recruitment end date
30/06/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Paediatric Oncologist
Oxford
OX3 9DV
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15801953
Publication citations
-
Results
Roy A, Bradburn M, Moorman AV, Burrett J, Love S, Kinsey SE, Mitchell C, Vora A, Eden T, Lilleyman JS, Hann I, Saha V, , Early response to induction is predictive of survival in childhood Philadelphia chromosome positive acute lymphoblastic leukaemia: results of the Medical Research Council ALL 97 trial., Br. J. Haematol., 2005, 129, 1, 35-44, doi: 10.1111/j.1365-2141.2005.05425.x.