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Brief Title: A Study for Older Adults With Acute Lymphoblastic Leukaemia
Official Title: A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
Study ID: NCT01616238
Brief Summary: The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to carry out a prospective, non randomised multi-arm study (including a choice of regimen intensity) to investigate the safety, tolerability and feasibility of a standardised therapy protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic standard of care upon which trials of novel therapies will be based in future. The design of the study will enable collection of a comprehensive dataset regarding the clinical outcome, Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously completely uncharacterised population, thus providing the essential platform for designing future randomised advanced phase studies in which new therapeutic approaches and novel therapies can be prospectively investigated.
Detailed Description: The study will 1. establish baseline expectations for Event Free Survival (EFS), Overall Survival (OS), MRD responses and quality of life measures for older patients of all ages and pre-morbid states; 2. disclose how best to use knowledge of pre-morbid characteristics to apply the appropriate intensity of therapy in order to balance the best disease related outcomes against quality of life; 3. establish national standards of care for this patient group; 4. provide the essential platform for careful design of future randomised advanced phase studies of new therapeutic approaches and agents.
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Erasmus MC, Rotterdam, , Netherlands
NHS Lanarkshire - Monklands, Airdrie, , United Kingdom
Blackpool Victoria Hopsital, Blackpool, , United Kingdom
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Bradford Royal Infirmary, Bradford, , United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
Castle Hill Hospital, Cottingham, , United Kingdom
Russells Hall Hospital, Dudley, , United Kingdom
Ninewells Hospital, Dundee, , United Kingdom
NHS Lothian - Western General Hospital, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
New Victoria Hospital and Southern General Hospital, Glasgow, , United Kingdom
Northwick Park Hospital, Harrow, , United Kingdom
St James' Hospital, Leeds, Leeds, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
King's College Hospital NHS Foundation Trust, London, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
St George's Hospital, London, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
James Cook University Hospital, Middlesbrough, , United Kingdom
Churchill Hospital, Oxford, Oxford, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Poole General Hospital, Poole, , United Kingdom
St Helen's & Knowlsey Teaching Hospitals, Prescot, , United Kingdom
Salisbury District Hospital, Salisbury, , United Kingdom
Royal Hallamshire Hospital, Sheffield, , United Kingdom
Royal MarsdenHospital, Sutton, , United Kingdom
Great Western Hospital, Swindon, , United Kingdom
Musgrove Park, Taunton, , United Kingdom
Torbay Hospital, Torquay, , United Kingdom
Sandwell General Hospital, West Bromwich, , United Kingdom
Arrowe Park Hospital, Wirral, , United Kingdom
Name: Prof Adele Fielding
Affiliation: University College London Hospital
Role: PRINCIPAL_INVESTIGATOR