United Kingdom Trial for children and young adults with Acute lymphoblastic... | Recruiting
United Kingdom Trial for children a... | Recruiting
United Kingdom Trial for children and young adults with Acute lymphoblastic Leukaemia and Lymphoma 2011
UKALL 2011

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Medical Conditions
  • Paediatric Oncology
  • Disease: Lymphoma (Hodgkin's), Leukaemia (acute lymphoblastic)
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN64515327
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-treatment-children-young-people-acute-lymphoblastic-leukaemia-lymphoma-ukall-2011
Research Details
  • The UKALL 2011 trial seeks to further refine treatment for children and young adults suffering from acute lymphoblastic leukaemia, which is the commonest cancer of childhood, and the rarer condition, lymphoblastic lymphoma.

    The aim is to improve survival whilst reducing the burden of therapy for patients, carers and the NHS. Although over 80% of patients with these diagnoses can be cured, there are considerable short term and long term side effects associated with the treatment.

    The UKALL 2011 trial will build on the current best available treatment and will assess whether changes in the way some of the standard anti-leukaemia drugs are given can reduce the side efefcts associated with treatment. The changes to be tested include:

    1. Modification of the scheduling of the steroid drug dexamethasone given in the first 4 weeks of treatment
    2. Modification of the type of treatment given to prevent the disease returning in the central nervous system (CNS)
    3. Modification of the type of 'maintenance treatment' used at the end of treatment
Phase
Phase III
Study Design
Randomised interventional treatment trial
Study Type
Interventional
Intervention

The trial will open in 27 UK principal treatment centres for children and young adults. Eligible patients will have acute lymphoblastic leukaemia or lymphoblastic lymphoma and will be aged between 1 and 25 years. Approximately 2640 patients will be recruited over 6 years.

The trial contains two randomisations and will investigate the following:

1. Randomisation 1 (R1) - dexamethasone randomisation:
In induction, the effect on serious treatment-related toxicity of receiving either a dexamethasone schedule of 10mg/m2 per day for a total of 14 days, or the current standard UK schedule of 6mg/m2 per day for 28 days.

2. Randomisation 2 (R2) - methotrexate and pulses randomisation:
In interim maintenance, the effect on CNS relapse risk and quality of life of receiving either high dose methotrexate without prolonged intrathecal therapy or the current standard UK CNS-directed ALL therapy with protracted intrathecal therapy.

3. Control:
In maintenance therapy, the effect in patients on bone marrow relapse risk and quality of line of receiving monthly pulses of vincristine and dexamethasone

Intervention Type
Drug
Primary Outcome Measures
    1. Dexamethasone Randomisation (1st Randomisation, R1)
    Induction steroid-induced morbidity and mortality defined as all serious adverse events and grade 3 or 4 adverse events related to induction and categorised as steroid related or steroid contributory
    2. Methotrexate Randomisation (2nd Randomisation, R2)
    Central nervous system (CNS) relapse, defined as any relapse with CNS involvement, including combined
    3. Pulses Randomisation (2nd Randomisation, R2)
    Bone marrow relapse, defined as any relapse with bone marrow involvement, including combined, Quality of Life measured by PedsQL
Secondary Outcome Measures
    1. Dexamethasone Randomisation (R1)
    Rate of remission, event free & overall survival
    2. Methotrexate Randomisation (R2)
    Event free and overall survival, Quality of Life measured by PedsQL, treatment related mortality and morbidity
    3. Pulses Randomisation (R2)
    Event free and overall survival, treatment related mortality and morbidity, local relapse (LBL)
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Child
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 2640; UK Sample Size: 2640
Participant Inclusion Criteria
    1. Aged 1 (first birthday) to 24 years 364 days (at time of diagnosis)
    2. First diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIG negative precursor B-NHL) diagnoses using standard criteria
    3. Male and female participants
Participant Exclusion Criteria
    1. Infants less than a year old at diagnosis
    2. Patients diagnosed with B-ALL (Burkitt-like, t(8;14), L3 morphology, SMIg positive)
    3. Patients diagnosed with Philadelphia-positive ALL (t(9;22) or BCR/ABL positive)
    4. Patients in whom written informed consent has not been obtained from parents and/or patients prior to randomisation
    5. Patients who have received previous treatment for ALL or lymphoblastic lymphoma (LBL) except those patients who have received dexamethasone treatment for no more than 7 days (due to clinical urgency) immediately prior to randomisation
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Pfizer Investigational Site
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Ms Clare Brittain
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
United Kingdom national randomised trial for children and young adults with Acute lymphoblastic Leukaemia and Lymphoma 2011
EudraCT Number
2010-020924-22
Funder(s)
  • Leukaemia & Lymphoma Research (UK)
Other Study ID Numbers
11319
Sponsor(s)
University of Birmingham (UK)
Key Dates

Recruitment Start Date

01 Jan 2012

Recruitment End Date

01 Jan 2018

Trial Start Date

01 Jan 2012

Trial End Date

01 Jan 2018

Date added to source

08 Dec 2011

Date updated in source

17 Dec 2012