Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Medical Research Council Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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