Medical Research Council (MRC) Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003
Recruitment status was: Recruiting
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:
- Can treatment be reduced without compromising efficacy in a MRD-defined low risk group?
- Does further post-remission intensification improve outcome for a MRD-defined high risk group?
- Measure the Quality of Life impact of the different treatment arms on the children and their families.
|Acute Lymphoblastic Leukemia||Other: Reduced intensification Drug: Standard childhood UK ALL protocol Drug: Intensified treatment including Capizzi maintenance||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Medical Research Council Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003|
- Event free survival [ Time Frame: 5 years ]
- Survival [ Time Frame: 5 years ]
- Quality of life [ Time Frame: 3 years ]
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Active Comparator: A or B with 2DI
3 or 4 drug induction plus 2 delayed intensifications
Drug: Standard childhood UK ALL protocol
No additional treatment to standard protocol.
Experimental: C plus 2DI
Intensified treatment including Capizzi maintenance
Drug: Intensified treatment including Capizzi maintenance
Augmented consolidation: vincristine, Peg-asparaginase. Capizzi maintenance: iv methotrexate and peg-asparaginase
Experimental: A or B with 1DI
Reduced intensity treatment
Other: Reduced intensification
Deletion of one 7 week treatment block containing dexamethasone, vincristine, doxorubicin, Peg-asparaginase, intrathecal methotrexate, cyclophosphamide, cytarabine.
Other Name: Removal of second delayed intensification
Patients will be assigned to MRD risk groups based on day 29 and post consolidation MRD results and randomised as follows:
- 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.
- MRD High Risk Group (MRD positive > 1 x 10-4 at day 29) randomised between previously assigned Regimen (A or B) and Regimen C.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222612
|Contact: Susan Richards, D Phil||Sue.Richards@ctsu.ox.ac.uk|
|Sheffield Children's Hospital||Recruiting|
|Sheffield, United Kingdom, S10 2TH|
|Contact: Ajay Vora firstname.lastname@example.org|
|Principal Investigator:||Ajay Vora||Sheffield Children's Hospital|