UKALL XI (92) - Acute lymphoblastic leukaemia trial

ISRCTN ISRCTN16757172
DOI https://doi.org/10.1186/ISRCTN16757172
Secondary identifying numbers G8223452
Submission date
25/10/2000
Registration date
25/10/2000
Last edited
01/09/2022
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 F Hill
Scientific

The Children's Hospital
Ladywood Middleway
Birmingham
B16 8ET
United Kingdom

Email none@example.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleUKALL XI (92) - Acute lymphoblastic leukaemia trial
Study acronymUKALL XI (92)
Study objectivesTo test if CNS disease eradication can be successfully achieved without cranial radiotherapy by using CNS directed chemotherapy, to determine whether the use of high-dose intravenous MTX as part of the CNS therapy will reduce the incidence of systematic relapse, to assess whether a third intensification block of chemotherapy effects disease free survival, to compare by psychometric testing the long term learning and neuropsychological effects of the different CNS treatments.

Please note that the target number of participants was added as of 18/07/2007.
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedLeukaemia
InterventionCentral Nervous System (CNS) directed chemotherapy/control
Intervention typeOther
Primary outcome measureDisease-free survival, CNS disease eradication, relapse rates, psychometric test results.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1990
Completion date31/12/1997

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit15 Years
SexBoth
Target number of participants2,090 children were recruited
Key inclusion criteriaThey are children including those with Down's syndrome or leukaemia associated chromosome translocations over 1 year and under 15 years with newly diagnosed ALL of any immunologic subtype except B-ALL
Key exclusion criteriaChildren with B-ALL and those under 1 year
Date of first enrolment01/01/1990
Date of final enrolment31/12/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Children's Hospital
Birmingham
B16 8ET
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 (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 planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 01/04/2001 Yes No
Results article 01/02/2002 Yes No
Results article 01/01/2004 Yes No
Results article 13/10/2011 01/09/2022 Yes No

Editorial Notes

01/09/2022: Publication reference added.