A Study for Older Adults With Acute Lymphoblastic Leukaemia
NCT ID: NCT01616238
Last Updated: 2023-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2012-12-31
2023-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Philadelphia Positive Patients
All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen
Chemotherapy
Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years.
Philadelphia -ve Patients- Intensive
Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.
Chemotherapy
Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years.
Philadelphia -ve Patients- Intensive +
Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group
Chemotherapy
Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years.
Philadelphia -ve Patients- Non Intensive
Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
Chemotherapy
Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years.
Registration only
Patients with either Philadelphia positive or negative ALL who do not wish to enter the study will be allocated to this group for data collection purposes only.
No interventions assigned to this group
Interventions
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Chemotherapy
Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years.
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before trial registration))
* Willing and able to give consent
Exclusion Criteria
* Blast transformation of CML
* Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24 ;q32) and variant c-myc translocations e.g. t(2;8)(p12 ;q24), t(8;22)(q24;q11)
* Women who are pregnant or lactating
55 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Stichting Hemato-Oncologie voor Volwassenen Nederland
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Prof Adele Fielding
Role: PRINCIPAL_INVESTIGATOR
University College London Hospital
Locations
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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
Arrowe Park Hospital
Metropolitan Borough of Wirral, , 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
Countries
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Other Identifiers
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UCL/11/0532
Identifier Type: -
Identifier Source: org_study_id
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