| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN16757172 |
| Date ISRCTN assigned | 25/10/2000 |
| Local reference number(s) | G8223452 |
| Public title | UKALL XI (92) - Acute lymphoblastic leukaemia trial |
| Scientific title |
|
| Acronym | UKALL XI (92) |
| Disease/condition/study domain | Leukaemia |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Children with B-ALL and those under 1 year |
| Patient information material |
|
| Anticipated start date | 01/01/1990 |
| Anticipated end date | 31/12/1997 |
| Status of trial | Completed |
| Target number of participants | Added as of 18/07/2007: 2090 children were recruited. |
| Interventions | Central Nervous System (CNS) directed chemotherapy/control |
| Primary outcome measure(s) | Disease-free survival, CNS disease eradication, relapse rates, psychometric test results. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11328289
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14675406
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11813173 |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr F Hill |
| Contact details | The Children's Hospital
Ladywood Middleway
Birmingham
United Kingdom
B16 8ET |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN16757172 |
| Date last extracted from ISRCTN register | 17/04/2008 |
