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A Comparison of Reduced Dose Total Body Irradiation (TBI) and Cyclophosphamide With Fludarabine and Melphalan Reduced Intensity Conditioning in Adults With Acute Lymphoblastic Leukaemia (ALL) in Complete Remission. (ALL-RIC)
Sponsor: University of Birmingham
Summary
The current national acute lymphoblastic leukaemia (ALL) trial in adults investigated whether a low (reduced) intensity chemotherapy regimen prior to transplant could improve the outcome of patients with ALL who are over 40 years of age. The results (60% 2 year survival) are very encouraging but patients who come to transplant with small amounts of 'residual' disease had less good outcomes. The goal of this trial is to see if a slightly stronger chemotherapy regimen (involving total body irradiation, (TBI)) can improve results by reducing the chance of the disease coming back (relapsing) without increasing the chance of not surviving the transplant. Up to 242 patients will be 'randomised' to the trial to receive either the established chemotherapy of fludarabine and melphalan or cyclophosphamide and TBI to compare the outcomes between the two treatment regimens. Other measures to reduce relapse will be the earlier use of donor white cell infusions and earlier stopping of immune suppressive drugs to enhance the immune effect of the transplanted cells (graft). Patients will be followed up for a minimum of 3 years. All patients on the next national ALL trial (UKALL XV) will be offered this trial but it will also be open to patients not on this study.
Key Details
Gender
All
Age Range
40 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
242
Start Date
2018-11-22
Completion Date
2027-11-22
Last Updated
2024-05-16
Healthy Volunteers
No
Conditions
Interventions
Fludarabine
IV
Melphalan
IV
Alemtuzumab
IV
Cyclophosphamide
IV
Mesna
IV
Total Body Irradiation (8Gy)
TBI (8Gy)
Locations (22)
Heart of England Nhs Foundation Trust
Birmingham, United Kingdom
University Hospitals Birmingham Nhs Foundation Trust
Birmingham, United Kingdom
University Hospitals Bristol Nhs Foundation Trust
Bristol, United Kingdom
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom
Cardiff and Vale University Health Board
Cardiff, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Leeds Teaching Hospitals Nhs Trust
Leeds, United Kingdom
University Hospitals of Leicester Nhs Trust
Leicester, United Kingdom
The Clatterbridge Cancer Centre Nhs Foundation Trust
Liverpool, United Kingdom
Barts Health Nhs Trust
London, United Kingdom
University College London Hospitals Nhs Foundation Trust
London, United Kingdom
Kings College Hospital
London, United Kingdom
The Royal Marsden Nhs Foundation Trust
London, United Kingdom
Imperial College Healthcare Nhs Trust
London, United Kingdom
The Christie Nhs Foundation Trust
Manchester, United Kingdom
Central Manchester University Hospitals Nhs Foundation Trust
Manchester, United Kingdom
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle, United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, United Kingdom
Oxford University Hospitals Nhs Foundation Trust
Oxford, United Kingdom
Plymouth Hospitals Nhs Trust
Plymouth, United Kingdom
Sheffield Teaching Hospitals Nhs Foundation Trust
Sheffield, United Kingdom
University Hospital Southampton Nhs Foundation Trust
Southampton, United Kingdom