United Kingdom childhood Acute Lymphoblastic Leukaemia Randomised Trial 2003
| ISRCTN | ISRCTN07355119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07355119 |
| ClinicalTrials.gov (NCT) | NCT00222612 |
| Protocol serial number | G0300130; 0301 |
| Sponsor | University of Sheffield (UK) |
| Funders | Medical Research Council (MRC) (UK) (ref: G0300130), Leukaemia Research Fund (UK) (ref: 0301) |
- Submission date
- 15/08/2003
- Registration date
- 18/08/2003
- Last edited
- 02/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
Roald Dahl Paediatric Haematology Centre
Sheffield Children's Hospital
Sheffield
S10 2TH
United Kingdom
| Phone | +44 (0)114 271 7477 |
|---|---|
| ajay.vora@sch.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised trial to evaluate whether treatment can be reduced without compromising effficacy in a low risk group of patients defined by a molecular minimal residual disease (MRD) technique; and to evaluate whether further post-remission intensification can improve outcome for a MRD-defined high risk group |
| Study acronym | MRC UKALL 2003 |
| Study objectives | Optimise treatment of childhood acute lymphoblastic leukaemia (ALL) by stratification according to on-treatment monitoring of minimal residual disease. |
| Ethics approval(s) | 1. MREC approval: Scotland A Research Ethics Committee, 25/02/2003, ref: 02/10/052 2. Medicines and Healthcare products Regulatory Agency (MHRA) approved of DDX Asparaginase Medac on 16/08/2002, DDX Oncaspar on 16/08/2002 and CTA Mercaptopurine 10 mg tablets on 16/06/2004 (ref: 18739/0205/001-0009) |
| Health condition(s) or problem(s) studied | Leukaemia |
| Intervention | MRD high risk group randomised to standard versus intensified therapy MRD low risk group randomised to standard versus reduced therapy Total duration of treatment was 2 years for girls, 3 years for boys and a 5 year follow-up for all arms. |
| Intervention type | Other |
| Primary outcome measure(s) |
Event-free survival, measured at 5 years |
| Key secondary outcome measure(s) |
1. Survival, measured at 5 years |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 2500 |
| Key inclusion criteria | Children aged 1 - 18 years with ALL As of 12/02/2010, young adults up to their 25th birthday are also eligible for this trial. |
| Key exclusion criteria | 1. Mature B ALL 2. Infant ALL (aged less than 1 year) 3. Philadelphia positive ALL |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
S10 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | results | 14/08/2014 | Yes | No | |
| Results article | results | 01/07/2018 | 02/08/2019 | Yes | No |
| Other publications | retrospective observational analysis | 05/10/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
02/08/2019: Publication reference added.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
19/10/2017: Publication reference added.
12/02/2010: The following changes were made to this trial record:
1. The overall trial end date was changed from 30/09/2009 to 01/08/2010
2. The sponsor was changed from the Medical Research Council (UK) to University of Sheffield (UK)
15/02/2011: The overall trial end date was changed from 01/08/2010 to 30/06/2011.
