UKALL XI (92) - Acute lymphoblastic leukaemia trial
ISRCTN | ISRCTN16757172 |
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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
Scientific
The Children's Hospital
Ladywood Middleway
Birmingham
B16 8ET
United Kingdom
none@example.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | UKALL XI (92) - Acute lymphoblastic leukaemia trial |
Study acronym | UKALL XI (92) |
Study objectives | 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(s) | Not provided at time of registration. |
Health condition(s) or problem(s) studied | Leukaemia |
Intervention | Central Nervous System (CNS) directed chemotherapy/control |
Intervention type | Other |
Primary outcome measure | Disease-free survival, CNS disease eradication, relapse rates, psychometric test results. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1990 |
Completion date | 31/12/1997 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Child |
Lower age limit | 1 Year |
Upper age limit | 15 Years |
Sex | Both |
Target number of participants | 2,090 children were recruited |
Key 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 |
Key exclusion criteria | Children with B-ALL and those under 1 year |
Date of first enrolment | 01/01/1990 |
Date of final enrolment | 31/12/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Children's Hospital
Birmingham
B16 8ET
United Kingdom
B16 8ET
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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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
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not 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.