ALL-RIC
Research type
Research Study
Full title
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.
IRAS ID
236871
Contact name
Sean Jennings
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2017-004800-23
Clinicaltrials.gov Identifier
ERN_17-1565, Ethics self assessment number
Duration of Study in the UK
7 years, 0 months, 1 days
Research 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 5 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.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0112
Date of REC Opinion
12 Jun 2018
REC opinion
Further Information Favourable Opinion