A prospective multicenter trial of peripheral blood stem cell sibling allografts for acute myeloid leukemia in first complete remission using fludarabine-cyclophosphamide reduced intensity conditioning
Date
2007
Authors
Grigg, A.
Gibson, J.
Bardy, P.
Reynolds, J.
Shuttleworth, P.
Koelmeyer, R.
Szer, J.
Roberts, A.
To, L.
Kennedy, G.
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Journal article
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Biology of Blood and Marrow Transplantation, 2007; 13(5):560-567
Statement of Responsibility
A.P. Grigg, J. Gibson, P.G. Bardy, J. Reynolds, P. Shuttleworth, R.L. Koelmeyer, J. Szer, A.W. Roberts, L.B. To, G. Kennedy and K.F. Bradstock
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Abstract
The role of allogeneic transplantation in patients with de novo acute myeloid leukemia in first complete remission (AML-CR1) is controversial. Aiming to preserve a graft-versus-leukemia effect, but minimize morbidity and mortality from conditioning-related toxicity and graft-versus-host disease (GVHD), we conducted a prospective multicenter study of reduced-intensity conditioning (RIC) as preparation for peripheral blood stem cell sibling allografts in patients with intermediate or poor risk AML-CR1. Conditioning consisted of fludarabine 125 mg/m(2) and cyclophosphamide 120 mg/kg. Thirty-four patients were transplanted with a median age of 45 years; 85% had intermediate risk cytogenetics. Early toxicity was minimal. The overall incidence of grade II-IV acute GVHD was low (21%), but the 3 patients (9%) who developed grade IV GVHD died. Donor T cell chimerism was rapid and generally complete, but complete myeloid chimerism was delayed. Thirteen patients (38%) relapsed, 12 within a year of transplant. The estimated disease-free survival (DFS) and overall survival at 2 years was 56% (95% confidence interval [CI] 39%-71%) and 68% (95% CI 50%-81%), respectively. The incidence of extensive chronic GVHD (cGVHD) was low (24% of surviving patients at 12 months) and most survivors had an excellent performance status. These observations justify a prospective comparison of RIC versus myeloablative conditioning allografts for AML-CR1.
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Copyright © 2007 American Society for Blood and Marrow Transplantation Published by Elsevier Inc.