United Kingdom Trial for children and young adults with Acute lymphoblastic Leukaemia and Lymphoma 2011

ISRCTN	ISRCTN64515327
DOI	https://doi.org/10.1186/ISRCTN64515327
EudraCT/CTIS number	2010-020924-22
Secondary identifying numbers	11319

Submission date: 08/12/2011
Registration date: 08/12/2011
Last edited: 17/09/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-treatment-children-young-people-acute-lymphoblastic-leukaemia-lymphoma-ukall-2011

Study website

Contact information

Ms Kate Chew
Scientific

Children’s Cancer Trials Team
Cancer Research UK Clinical Trials Unit (CRCTU)
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	ukall2011@trials.bham.ac.uk

Study information

Study design	Randomized interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	United Kingdom national randomised trial for children and young adults with Acute lymphoblastic Leukaemia and Lymphoma 2011
Study 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(s)	North Thames REC, 06/12/2011, ref: 11/LO/1487
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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Dexamethasone, methotrexate, vincristine
Primary outcome measure	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 Added 08/03/2018: Any event defined as relapse, secondary tumour or death from any cause is also a primary outcome measure for each randomised comparison and the trial overall.
Secondary outcome measures	1. Dexamethasone Randomisation (R1) Rate of remission, event free and 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) Added 08/03/2018: 4. Overall trial population Event free and overall survival, relapse rate, treatment related mortality and morbidity compared to the results from the UKALL 2003 trial
Overall study start date	01/01/2012
Overall study end date	31/12/2027

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	1 Year
Upper age limit	24 Years
Sex	Both
Target number of participants	Planned Sample Size: 2640; UK Sample Size: 2640
Total final enrolment	2822
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
Recruitment start date	01/01/2012
Recruitment end date	31/12/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Birmingham Clinical Trials Unit

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

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

Website	http://www.birmingham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Charity

Bloodwise
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2028
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 3.0	01/10/2013	05/05/2023	No	No
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN64515327_Protocol_v3.0_01Oct2013.pdf

Editorial Notes

17/09/2024: Contact details updated.
05/05/2023: Protocol file uploaded.
16/03/2023: The total final enrolment was added.
09/01/2019: The primary contact details were updated.
08/03/2018: The following changes were made to the trial record:
1. Contact details updated.
2. Ethics approval details added.
3. Primary and secondary outcome measures updated.
4. Publication and dissemination plan and IPD sharing statement added.
14/02/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2018 to 31/12/2018.
2. The overall trial end date was changed from 01/01/2018 to 31/12/2027.
3. The funder was changed from Leukaemia and Lymphoma Research to Bloodwise.