Condition category
Cancer
Date applied
15/08/2003
Date assigned
18/08/2003
Last edited
10/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Ajay Vora

ORCID ID

Contact details

Roald Dahl Paediatric Haematology Centre
Sheffield Children's Hospital
Sheffield
S10 2TH
United Kingdom
+44 (0)114 271 7477
ajay.vora@sch.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00222612

Protocol/serial number

G0300130; 0301

Study information

Scientific title

A randomised trial to evaluate whether treatment can be reduced without compromising effficacy in a low risk group of patients defined by a molecular minimal residual disease (MRD) technique; and to evaluate whether further post-remission intensification can improve outcome for a MRD-defined high risk group

Acronym

MRC UKALL 2003

Study hypothesis

Optimise treatment of childhood acute lymphoblastic leukaemia (ALL) by stratification according to on-treatment monitoring of minimal residual disease.

On 12/02/2010 the following changes were made to this trial record:
1. The anticipated end date was changed from 30/09/2009 to 01/08/2010
2. The sponsor was changed from the Medical Research Council (UK) to University of Sheffield (UK)

On 15/02/2011 the anticipated end date was changed from 01/08/2010 to 30/06/2011.

Ethics approval

1. MREC approval: Scotland A Research Ethics Committee, 25/02/2003, ref: 02/10/052
2. Medicines and Healthcare products Regulatory Agency (MHRA) approved of DDX Asparaginase Medac on 16/08/2002, DDX Oncaspar on 16/08/2002 and CTA Mercaptopurine 10 mg tablets on 16/06/2004 (ref: 18739/0205/001-0009)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.ctsu.ox.ac.uk/projects/leuk/ukall2003/

Condition

Leukaemia

Intervention

MRD high risk group randomised to standard versus intensified therapy
MRD low risk group randomised to standard versus reduced therapy

Total duration of treatment was 2 years for girls, 3 years for boys and a 5 year follow-up for all arms.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Event-free survival, measured at 5 years

Secondary outcome measures

1. Survival, measured at 5 years
2. Quality of life, measured at week 1, week 4, start of maintenance treatment, 18 months, end of treatment
3. Complete response (CR) rate measured at 4 weeks

Overall trial start date

01/10/2003

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 1 - 18 years with ALL

As of 12/02/2010, young adults up to their 25th birthday are also eligible for this trial.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

2,500

Participant exclusion criteria

1. Mature B ALL
2. Infant ALL (aged less than 1 year)
3. Philadelphia positive ALL

Recruitment start date

01/10/2003

Recruitment end date

30/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Roald Dahl Paediatric Haematology Centre
Sheffield
S10 2TH
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

The Research Office
New Spring House
231 Glossop Road
Sheffield
S10 2GS
United Kingdom
+44 (0)114 222 1448
r.j.hudson@shef.ac.uk

Sponsor type

University/education

Website

http://www.shef.ac.uk/

Funders

Funder type

Government

Funder name

Medical Research Council (MRC) (UK) (ref: G0300130)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Leukaemia Research Fund (UK) (ref: 0301)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23395119
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24904116
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24924991

Publication citations

  1. Results

    Vora A, Goulden N, Wade R, Mitchell C, Hancock J, Hough R, Rowntree C, Richards S, 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, doi: 10.1016/S1470-2045(12)70600-9.

  2. Results

    O'Connor D, Bate J, Wade R, Clack R, Dhir S, Hough R, Vora A, Goulden N, Samarasinghe S, Infection-related mortality in children with acute lymphoblastic leukemia: an analysis of infectious deaths on UKALL2003., Blood, 2014, 124, 7, 1056-1061, doi: 10.1182/blood-2014-03-560847.

  3. Results

    Vora A, Goulden N, Mitchell C, Hancock J, Hough R, Rowntree C, Moorman AV, Wade R, Augmented post-remission therapy for a minimal residual disease-defined high-risk subgroup of children and young people with clinical standard-risk and intermediate-risk acute lymphoblastic leukaemia (UKALL 2003): a randomised controlled trial., Lancet Oncol., 2014, 15, 8, 809-818, doi: 10.1016/S1470-2045(14)70243-8.

Additional files

Editorial Notes