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

Phase 4

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Standard childhood UK ALL protocol; Drug: Intensified treatment including Capizzi maintenance; Other: Reduced intensification

• Registration Number: NCT00222612
• Lead Sponsor: University of Oxford

Brief Summary

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 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

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-03
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A or B with 2DI	Standard childhood UK ALL protocol	3 or 4 drug induction plus 2 delayed intensifications
C plus 2DI	Intensified treatment including Capizzi maintenance	Intensified treatment including Capizzi maintenance
A or B with 1DI	Reduced intensification	Reduced intensity treatment

Primary Outcome Measures

Name	Time	Method
Event free survival	5 years

Secondary Outcome Measures

Name	Time	Method
Survival	5 years
Quality of life	3 years

Trial Locations

Locations (1)

Sheffield Children's Hospital; 🇬🇧 Sheffield, United Kingdom