1. ¹City of Hope National Medical Center, Duarte, CA, USA
2. ²Southern California Permanente Medical Group, Los Angeles, CA, USA
3. ³City of Hope – Good Samaritan Bone Marrow Transplantation Program, Phoenix, AZ, USA

Correspondence: Dr R Rodriguez, City of Hope National Medical Center, Division of Hematology and Bone Marrow Transplantation, 1500 E Duarte Road, Duarte, CA 91010, USA. E-mail: robertorodriguez@coh.org

Received 20 October 2003; Accepted 18 December 2003; Published online 5 April 2004.

Abstract

In an attempt to decrease toxicity in high-risk patients undergoing unrelated donor hematopoietic stem cell transplantation (URD HSCT), we tested a combination of cyclosporine (CSP) and mycophenolate mofetil (MMF) as graft-versus-host disease (GVHD) prophylaxis with the reduced-intensity conditioning regimen fludarabine/melphalan (Flu/Mel). A total of 22 adult patients with advanced myeloid (n=15) and lymphoid (n=7) malignancies were treated. All patients received Flu 25 mg/m² for 5 days and Mel 140 mg/m², with CSP 3 mg/kg daily and MMF 15 mg/kg three times a day. The median age was 49 years (range 18–66). Durable engraftment was seen in all but one patient with myelofibrosis. The 1-year nonrelapse mortality was 32%, 27% from GVHD. The cumulative incidence of acute GVHD grade 2–4 and 3–4 was 63 and 41%, respectively. With a median follow-up of 18 months, the disease-free survival (DFS) and overall survival (OS) are 55 and 59%, respectively. For patients with AML and MDS (n=14), the DFS and OS is 71%. For patients undergoing a second transplant (n=14), the DFS and OS is 57%. In conclusion, this regimen is associated with acceptable toxicity but high rates of GVHD in high-risk patients undergoing URD HSCT. Encouraging disease control for patients with advanced myeloid malignancies was observed.