Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
13/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr C Mitchell

ORCID ID

Contact details

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

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15801953

Publication citations

  1. 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.

Additional files

Editorial Notes