Medical Research Council (MRC) Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003
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|ClinicalTrials.gov Identifier: NCT00222612|
Recruitment Status : Unknown
Verified February 2010 by University of Oxford.
Recruitment status was: Recruiting
First Posted : September 22, 2005
Last Update Posted : February 3, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Other: Reduced intensification Drug: Standard childhood UK ALL protocol Drug: Intensified treatment including Capizzi maintenance||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Medical Research Council Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003|
|Study Start Date :||October 2003|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
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
- Event free survival [ Time Frame: 5 years ]
- Survival [ Time Frame: 5 years ]
- Quality of life [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|