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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Medical Research Council
Information provided by:
University of Oxford

Study Description
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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 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.

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

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 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.
  2. MRD High Risk Group (MRD positive > 1 x 10-4 at day 29) randomised between previously assigned Regimen (A or B) and Regimen C.
  3. 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2003
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Event free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: 5 years ]
  2. Quality of life [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Children aged 1 - 18 years with ALL except the following:

Exclusion criteria:

  1. Infants less than a year old should be entered onto the Interfant ALL study.
  2. 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.
  3. 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:

  1. 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.
  2. 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.
  3. 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:

  1. Standard risk, (around 60-65% of the total): regimen A - three-drug induction.
  2. Intermediate risk, (around 20- 30% of the total): regimen B - four-drug induction.
  3. 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:

  1. Standard or Intermediate Risk as defined above.
  2. Morphological Complete Remission (BM1 Marrow) at Day 29 of Induction.
  3. Availability of MRD results at Day 28 and after consolidation therapy.
  4. Informed consent obtained.
  5. Induction given as protocol.

Exclusion criteria for entry into the MRD randomisation:

  1. High Risk as defined above. These patients will receive Regimen C.
  2. 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).
  3. 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.
  4. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Susan Richards, D Phil Sue.Richards@ctsu.ox.ac.uk

Locations
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United Kingdom
Sheffield Children's Hospital Recruiting
Sheffield, United Kingdom, S10 2TH
Contact: Ajay Vora       ajay.vora@sch.nhs.uk   
Sponsors and Collaborators
University of Oxford
Medical Research Council
Investigators
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Principal Investigator: Ajay Vora Sheffield Children's Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Vora, Sheffield University
ClinicalTrials.gov Identifier: NCT00222612    
Other Study ID Numbers: UKALL2003
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases