UKALL60+
Research type
Research Study
Full title
A Phase 2 study for older adults with Acute Lymphoblastic Leukaemia
IRAS ID
95993
Contact name
Adele Fielding
Contact email
Sponsor organisation
University College London
Eudract number
2011-005758-79
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 9 months, 30 days
Research summary
The chief aim of the UKALL60+ study is to document the safety, efficacy and feasibility of four commonly-used treatment regimens.\n\nThere are four treatment pathways available. Patients will be registered to the pathway that their treating clinician deems most suitable for their disease type and their fitness (informed by performance status and co-morbidity scoring). The patient’s wishes will also be taken into account:\n- Pathway A: Philadelphia positive - if a patient’s leukaemia has a genetic variation called the Philadelphia Chromosome, they will receive slightly different treatment, including an additional drug (Imatinib).\n- Pathway B: Intensive – one of two options available for Philadelphia negative patients with good performance status and few co-morbidities. This is a commonly-used regimen in the UK for fit older patients.\n- Pathway C: Intensive+ - one of two options available for Philadelphia negative patients with good performance status and few co-morbidities; considered more intensive than pathway B.\n- Pathway D: Non-intensive – this option is intended for patients with poor performance status. Some fitter patients may also elect to enter this pathway if they do not wish to have intensive treatment.\nPathway A-D treatment will consist of multiple phases of chemotherapy, and will last up to 2 ½ years. These patients will start with two phases of induction chemotherapy, aimed at achieving remission, and they will then go on to have further chemotherapy aimed at consolidating and maintaining their remission.\n\nThere is also a registration-only option (pathway E), which will collect basic data about treatment given and outcome if none of the four pathways are considered suitable, or the patient does not wish to have all the trial interventions required on pathways A-D.\n\nUp to four bone marrow samples per patient will be taken for sequential Minimal Residual Disease assessment.\n\nQuality of life will also be assessed throughout treatment.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0859
Date of REC Opinion
13 May 2016
REC opinion
Favourable Opinion