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ACTIVE NOT RECRUITING
NCT03821610
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Fludarabine

IV

DRUG

Melphalan

IV

DRUG

Alemtuzumab

IV

DRUG

Cyclophosphamide

IV

DRUG

Mesna

IV

RADIATION

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