Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G8223452
Study information
Scientific title
Acronym
UKALL XI (92)
Study hypothesis
To 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
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Leukaemia
Intervention
Central Nervous System (CNS) directed chemotherapy/control
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Disease-free survival, CNS disease eradication, relapse rates, psychometric test results.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
31/12/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
They 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2,090 children were recruited
Participant exclusion criteria
Children with B-ALL and those under 1 year
Recruitment start date
01/01/1990
Recruitment end date
31/12/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Children's Hospital
Birmingham
B16 8ET
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 (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/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
Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/11328289
2. http://www.ncbi.nlm.nih.gov/pubmed/14675406
3. http://www.ncbi.nlm.nih.gov/pubmed/11813173
Publication citations
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Hann I, Vora A, Harrison G, Harrison C, Eden O, Hill F, Gibson B, Richards S, , Determinants of outcome after intensified therapy of childhood lymphoblastic leukaemia: results from Medical Research Council United Kingdom acute lymphoblastic leukaemia XI protocol., Br. J. Haematol., 2001, 113, 1, 103-114.
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Hill FG, Richards S, Gibson B, Hann I, Lilleyman J, Kinsey S, Mitchell C, Harrison CJ, Eden OB, , Successful treatment without cranial radiotherapy of children receiving intensified chemotherapy for acute lymphoblastic leukaemia: results of the risk-stratified randomized central nervous system treatment trial MRC UKALL XI (ISRC TN 16757172)., Br. J. Haematol., 2004, 124, 1, 33-46.
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Little MA, Morland B, Chisholm J, Hole A, Shankar A, Devine T, Easlea D, Meyer LC, Pinkerton CR, A randomised study of prophylactic G-CSF following MRC UKALL XI intensification regimen in childhood ALL and T-NHL., Med. Pediatr. Oncol., 2002, 38, 2, 98-103.