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

NCT00222612 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2100

Last updated 2010-02-03

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Reduced intensification

Deletion of one 7 week treatment block containing dexamethasone, vincristine, doxorubicin, Peg-asparaginase, intrathecal methotrexate, cyclophosphamide, cytarabine.

DRUG

Standard childhood UK ALL protocol

No additional treatment to standard protocol.

DRUG

Intensified treatment including Capizzi maintenance

Augmented consolidation: vincristine, Peg-asparaginase. Capizzi maintenance: iv methotrexate and peg-asparaginase

Sponsors & Collaborators

Principal Investigators

  • Ajay Vora · Sheffield Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00222612 on ClinicalTrials.gov