United Kingdom childhood Acute Lymphoblastic Leukaemia Randomised Trial 2003
| ISRCTN | ISRCTN07355119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07355119 |
| ClinicalTrials.gov number | NCT00222612 |
| Secondary identifying numbers | G0300130; 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Ajay Vora
Scientific
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.ctsu.ox.ac.uk/projects/leuk/ukall2003/ |
| 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 | Event-free survival, measured at 5 years |
| Secondary outcome measures | 1. Survival, measured at 5 years 2. Quality of life, measured at week 1, week 4, start of maintenance treatment, 18 months, end of treatment 3. Complete response (CR) rate measured at 4 weeks |
| Overall study start date | 01/10/2003 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2,500 |
| 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
- England
- United Kingdom
Study participating centre
Sheffield Children's Hospital
Sheffield
S10 2TH
United Kingdom
S10 2TH
United Kingdom
Sponsor information
University of Sheffield (UK)
University/education
University/education
The Research Office
New Spring House
231 Glossop Road
Sheffield
S10 2GS
England
United Kingdom
| Phone | +44 (0)114 222 1448 |
|---|---|
| r.j.hudson@shef.ac.uk | |
| Website | http://www.shef.ac.uk/ |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Government
Medical Research Council (MRC) (UK) (ref: G0300130)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Leukaemia Research Fund (UK) (ref: 0301)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/03/2013 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | results | 14/08/2014 | Yes | No | |
| Other publications | retrospective observational analysis | 05/10/2017 | Yes | No | |
| Results article | results | 01/07/2018 | 02/08/2019 | Yes | No |
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.
