Incorporation of 8Gy total body irradiation into reduced intensity conditioning does not improve allogeneic transplant outcomes for high-risk adult acute lymphoblastic leukemia: Results from the randomised prospective phase 2 UK multicentre ALL-RIC impact study
Randomised trial found no improvement in outcomes for high-risk patients with acute lymphoblastic leukemia using 8Gy total body irradiation.
Key Points
This research aims to determine if adding 8Gy total body irradiation improves outcomes in high-risk adult acute lymphoblastic leukemia patients undergoing allogeneic stem cell transplant.
A randomised comparison of fludarabine, melphalan, alemtuzumab (FMA) regimen and cyclophosphamide plus 8Gy TBI regimen in adult patients.
Patients had intrathecal prophylaxis and donor lymphocyte infusions permitted for minimal residual disease post-SCT.
Primary endpoint was disease-free survival with several secondary endpoints including overall survival and graft-versus-host disease rates.
At 3 years, disease-free survival rates were similar for FMA (50%) and Cy/8TBI (48%).
No significant differences in cumulative incidence of relapse (31% vs 36%) or non-relapse mortality (19% vs 16%).
Overall survival rates at 3 years were 61% for FMA and 58% for Cy/8TBI, showing no superiority of either regimen.