Status:
UNKNOWN
Medical Research Council (MRC) Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Medical Research Council
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
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 w...
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Children aged 1 - 18 years with ALL except the following:
- Exclusion criteria:
- Infants less than a year old should be entered onto the Interfant ALL study.
- Children with B-ALL (Burkitt-like, t(8;14), L3 morphology, SMIg positive). Patients with this disease will be eligible for the current UKCCSG B cell NHL/ALL trial.
- Children with Philadelphia-positive ALL (t(9;22) or BCR/ABL positive) will start induction therapy on this protocol but transfer to the European Intergroup Protocol as soon as their Philadelphia status is known.
- Initially, eligible patients will be stratified into three risk groups based on the following criteria:
- Standard risk: all children \>1\<10 years with a highest white cell count before starting treatment of \<50x109/l, and who do not have BCR-ABL, hypodiploidy (≥44 chromosomes), or an MLL gene rearrangement.
- Intermediate risk: all children ≥10 years old, or with a diagnostic WBC ≥50x109/l (or both) and who do not have BCR-ABL, hypodiploidy (≥44 chromosomes), or an MLL gene rearrangement.
- High Risk: all children, irrespective of initial risk category, who have a slow early response (SER) as defined below - see section 6 - together with those who have BCR-ABL (induction only), hypodiploidy (≥44 chromosomes), or an MLL gene rearrangement. These patients will not be eligible for MRD randomisation.
- Patients will then start treatment according to their risk group as follows:
- Standard risk, (around 60-65% of the total): regimen A - three-drug induction.
- Intermediate risk, (around 20- 30% of the total): regimen B - four-drug induction.
- High risk (around 10-12% of the total): These patients will not be eligible for MRD randomisation. They will be allocated regimen C - four drug induction, augmented BFM consolidation, Capizzi interim maintenance, and two further BFM-style intensification periods of extended duration.
- Inclusion criteria for entry into the randomisations:
- Standard or Intermediate Risk as defined above.
- Morphological Complete Remission (BM1 Marrow) at Day 29 of Induction.
- Availability of MRD results at Day 28 and after consolidation therapy.
- Informed consent obtained.
- Induction given as protocol.
- Exclusion criteria for entry into the MRD randomisation:
- High Risk as defined above. These patients will receive Regimen C.
- Day 28 non-remitters. These patients will receive Regimen C if BM2 or go off-protocol if BM3 (see below for definitions of BM2 and BM3).
- MRD Indeterminate Group (No result or MRD positive \< 1 x 10-4 at day 28 and after consolidation therapy) will continue on previously assigned therapy.
- Sub-optimal induction therapy. The clinical significance of day 28 MRD is uncertain in patients who have received sub-optimal induction therapy. Please discuss these patients with a co-ordinator.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT00222612
Start Date
October 1 2003
End Date
August 1 2013
Last Update
February 3 2010
Active Locations (1)
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1
Sheffield Children's Hospital
Sheffield, United Kingdom, S10 2TH