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| [ Print-friendly version ] |
| United Kingdom Trial for children and young adults with Acute lymphoblastic Leukaemia and Lymphoma 2011 |
| ISRCTN | ISRCTN64515327 |
| ClinicalTrials.gov identifier | |
| Public title | United Kingdom Trial for children and young adults with Acute lymphoblastic Leukaemia and Lymphoma 2011 |
| Scientific title | United Kingdom national randomised trial for children and young adults with Acute lymphoblastic Leukaemia and Lymphoma 2011 |
| Acronym | UKALL 2011 |
| Serial number at source | 11319 |
| 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 |
| Lay summary | Not provided at time of registration |
| Ethics approval | ref: 11/LO/1487 |
| Study design | Randomised interventional treatment trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Paediatric Oncology; Disease: Lymphoma (Hodgkin's), Leukaemia (acute lymphoblastic) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2012 |
| Anticipated end date | 01/01/2018 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | Planned Sample Size: 2640; UK Sample Size: 2640 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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) |
| Sources of funding | Leukaemia & Lymphoma Research (UK) |
| Trial website | |
| Publications | |
| Contact name | Ms Clare Brittain |
| Address |
Birmingham Clinical Trials Unit
Division of Cancer Studies Robert Aitken Institute Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| ukall2011@trials.bham.ac.uk | |
| Sponsor | University of Birmingham (UK) |
| Address |
Cancer Research UK
Clinical Trials Unit Institute for Cancer Studies Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Sponsor website: | http://www.birmingham.ac.uk/ |
| Date applied | 08/12/2011 |
| Last edited | 08/12/2011 |
| Date ISRCTN assigned | 08/12/2011 |
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| © 2012 ISRCTN unless otherwise stated. | |
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