Condition category
Cancer
Date applied
08/12/2011
Date assigned
08/12/2011
Last edited
17/12/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Ms Clare Brittain

ORCID ID

Contact details

Birmingham Clinical Trials Unit
Division of Cancer Studies
Robert Aitken Institute
Edgbaston
Birmingham
B15 2TT
United Kingdom
ukall2011@trials.bham.ac.uk

Additional identifiers

EudraCT number

2010-020924-22

ClinicalTrials.gov number

Protocol/serial number

11319

Study information

Scientific title

United Kingdom national randomised trial for children and young adults with Acute lymphoblastic Leukaemia and Lymphoma 2011

Acronym

UKALL 2011

Study hypothesis

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

Ethics approval

ref: 11/LO/1487

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Paediatric Oncology; Disease: Lymphoma (Hodgkin's), Leukaemia (acute lymphoblastic)

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

Phase

Phase III

Drug names

Dexamethasone, methotrexate, vincristine

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)

Overall trial start date

01/01/2012

Overall trial end date

01/01/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 2640; UK Sample Size: 2640

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

Recruitment start date

01/01/2012

Recruitment end date

01/01/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Cancer Research UK
Clinical Trials Unit
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/

Funders

Funder type

Charity

Funder name

Leukaemia & Lymphoma Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes