| Source of record | UK Trials |
| ISRCTN | ISRCTN07355119 |
| Date ISRCTN assigned | 18/08/2003 |
| Local reference number(s) | G0300130 |
| Public title | United Kingdom childhood Acute Lymphoblastic Leukaemia Randomised Trial 2003 |
| Scientific title |
|
| Acronym | MRC UKALL 2003 |
| Disease/condition/study domain | Leukaemia |
| Study hypothesis | Optimise treatment of childhood ALL by stratification according to on-treatment monitoring of minimal residual disease. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Children aged 1-18 years with Acute Lymphoblastic Leukaemia (ALL) |
| Participants - exclusion criteria | 1. Mature B ALL
2. Infant ALL (age <1 year)
3. Philadelphia positive ALL |
| Patient information material |
|
| Anticipated start date | 01/10/2003 |
| Anticipated end date | 30/09/2009 |
| Status of trial | Ongoing |
| Target number of participants | 2500 |
| Interventions | MRD High Risk group randomised to standard vs intensified therapy
MRD Low Risk group randomised to standard vs reduced therapy |
| Primary outcome measure(s) | 1. Event-Free Survival
2. Survival
3. Quality of Life |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Medical Research Council (G0300130) (UK)
Leukaemia Research Fund (0301) (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7670 5259 |
| Sponsor fax | +44 (0)20 7636 6289 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Contact name | Dr Ajay Vora |
| Contact details | Roald Dahl Paediatric Haematology Centre
Sheffield Children's Hospital
SHEFFIELD
United Kingdom
S10 2TH |
| Contact telephone | +44 (0)114 2717477 |
| Contact fax | +44 (0)1142762289 |
| Contact email | ajay.vora@sch.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN07355119 |
| Date last extracted from ISRCTN register | 17/04/2008 |
