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UKALL 2003

Needs review

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

N = 521NCT00222612

Population
Children and young adults aged 1 to 25 years with ALL classified as MRD low risk (521 randomised of 3207 registered)
Design
Randomised, unmasked trial in the UK and Ireland (recruitment 1 October 2003 to 30 June 2011). Patients aged 1 to 25 years were assigned to clinical risk groups, and clinical standard-risk and intermediate-risk patients were assessed for MRD. Those with low-risk MRD (undetectable at end of induction, or detectable at day 29 and undetectable by week 11) were randomly assigned to one or two delayed intensification courses. The aim was to rule out a 7% reduction in EFS with one course. Analyses were by intention to treat.
Primary endpoint
EFS
Arms
  • Two delayed intensifications (control, n = 261): Two courses of delayed intensification (pegylated asparaginase; vincristine, dexamethasone and doxorubicin; cyclophosphamide and cytarabine)
  • One delayed intensification (experimental, n = 260): One course of delayed intensification
People
Vora A, senior author Richards S
Δ 60-month EFS−1.1 pointsΔ 60-month Actuarial relapse+3.2 points
Show the numbers
Results reported for UKALL 2003
EndpointAnalysisOne delayed intensificationTwo delayed intensificationsEffect
EFSMRD low-risk randomised patients, intention to treat (521)Time to relapse, secondary tumour or deathprimarymedian follow-up 57 monthsVora 201394.4% at 5 y (91.1–97.7%)95.5% at 5 y (92.8–98.2%)P=0.99No significant difference. Unadjusted odds ratio 1.00 (95% CI 0.43 to 2.31); two-sided P. Median follow-up 57 months (IQR 42 to 72).
Actuarial relapseMRD low-risk randomised patients (521)primaryVora 20135.6% at 5 y (2.3–8.9%)2.4% at 5 y (0.2–4.6%)P=0.23Actuarial relapse at 5 years; 11 patients relapsed with one delayed intensification and 6 with two.
Results reported for UKALL 2003
EndpointAnalysisOne delayed intensificationTwo delayed intensificationsEffect
EFSMRD low-risk randomised patients, intention to treat (521)Time to relapse, secondary tumour or deathprimarymedian follow-up 57 monthsVora 201394.4% at 5 y (91.1–97.7%)95.5% at 5 y (92.8–98.2%)P=0.99No significant difference. Unadjusted odds ratio 1.00 (95% CI 0.43 to 2.31); two-sided P. Median follow-up 57 months (IQR 42 to 72).
Actuarial relapseMRD low-risk randomised patients (521)primaryVora 20135.6% at 5 y (2.3–8.9%)2.4% at 5 y (0.2–4.6%)P=0.23Actuarial relapse at 5 years; 11 patients relapsed with one delayed intensification and 6 with two.
Primary publication: Vora A, Goulden N, Wade R, Mitchell C, Hancock J, Hough R, et al. Treatment reduction for children and young adults with low-risk acute lymphoblastic leukaemia defined by minimal residual disease (UKALL 2003): a randomised controlled trial. Lancet Oncol. 2013;14(3):199-209. PubMedDOI

Appears in

Sources

  1. Vora A, Goulden N, Wade R, Mitchell C, Hancock J, Hough R, et al. Treatment reduction for children and young adults with low-risk acute lymphoblastic leukaemia defined by minimal residual disease (UKALL 2003): a randomised controlled trial. Lancet Oncol. 2013;14(3):199-209.

    PubMedDOI