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
Study design/Summary: This is a 2 arm, phase II, multicentre, randomised clinical trial in adult patients with Acute Lymphoblastic Leukaemia (ALL) in complete remission (CR) undergoing a allogeneic stem cell transplant (SCT) comparing the novel conditioning regimen of TBI and cyclophosphamide with the standard conditioning of fludarabine/melphalan/alemtuzumab (FMA)
Objectives: The primary objectives of this study are to compare the disease free survival at two years of patients with ALL after a TBI and cyclophosphamide stem cell transplant with that of patients transplanted using the FMA conditioning regimen. There are also other objectives in addition to the primary one which include; overall survival; cumulative incidence of disease relapse, non-relapse mortality; incidence of grade 2-4 acute graft-versus-host-disease (GvHD), incidence of chronic GvHD of any grade, occurrence and severity of veno-occlusive disease (VOD); duration of hospitalisation in the first year; quality of file, full donor chimerism at day 100 and TBI related symptomatic pulmonary toxicity following allogenic SCT.
Centres: 22 IMPACT centres
Target number of patients: 242 patients
Patient population: Patients with ALL who are suitable to undergo an allogenic SCT
Sponsorship/Funding: University of Birmingham, funded by the IMPACT network
Trial Status: Temporary hold
Trial Contacts: ALL-RIC@trials.bham.ac.uk
Start date: 17 September 2018
Duration: 7 years
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