Last updated on February 2010

Medical Research Council (MRC) Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003

Brief description of study

A randomised trial for children with acute lymphoblastic leukemia, using the detection of minimal residual disease to define risk groups, aiming to answer the questions: 1. Can treatment be reduced without compromising efficacy in a MRD-defined low risk group? 2. Does further post-remission intensification improve outcome for a MRD-defined high risk group? 3. Measure the Quality of Life impact of the different treatment arms on the children and their families.

Detailed Study Description

Randomisations Patients will be assigned to MRD risk groups based on day 29 and post consolidation MRD results and randomised as follows: 1. MRD Low Risk Group (MRD negative at day 29 and week 11 or positive <1 x 10-4 at day 28 and negative at week 11) will continue on previously assigned Regimens (A or B) but randomised between two delayed intensifications and one delayed intensification. 2. MRD High Risk Group (MRD positive > 1 x 10-4 at day 29) randomised between previously assigned Regimen (A or B) and Regimen C. 3. MRD Indeterminate Group (No MRD result or MRD positive <1 x 10-4 at day 29 and at week 11) will continue on previously assigned Regimen (A or B) and received two delayed intensifications

Clinical Study Identifier: NCT00222612

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