MRC ALL 97 - UK national lymphoblastic leukaemia (ALL) trial

ISRCTN ISRCTN26727615
DOI https://doi.org/10.1186/ISRCTN26727615
ClinicalTrials.gov number NCT00003437
Secondary identifying numbers G8223452
Submission date
25/10/2000
Registration date
25/10/2000
Last edited
13/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr C Mitchell
Scientific

Consultant Paediatric Oncologist
John Radcliffe Hospital
Headington
Oxford
OX3 9DV
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymMRC ALL 97
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLeukaemia
InterventionOral prednisolone/dexamethasone/Oral 6-mercaptopurine/6-thioguanine
Intervention typeOther
Primary outcome measure1. Disease-free survival
2. CNS disease eradication
3. Relapse rates
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1997
Completion date30/06/2002

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit18 Years
SexNot Specified
Target number of participants1800
Key inclusion criteriaOpen to all children with ALL except those in 'Exclusions'
Key exclusion criteria1. 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)
Date of first enrolment01/01/1997
Date of final enrolment30/06/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Consultant Paediatric Oncologist
Oxford
OX3 9DV
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2005 Yes No