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United Kingdom childhood Acute Lymphoblastic Leukaemia Randomised Trial 2003

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN07355119
Enrollment
2500
Registered
2003-08-18
Start date
2003-10-01
Completion date
Unknown
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukaemia Cancer Lymphoid leukaemia

Interventions

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

Sponsors

University of Sheffield (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Event-free survival, measured at 5 years

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026