Phase I Study Of Bortezomib Combined With Lenalidomide For Relapsed Acute Myeloid Leukemia (Aml) Or Myelodysplastic Syndrome (Mds) Following Hematopoietic Cell Transplantation

Introduction: Allogeneic hematopoietic cell transplantation (HCT) is a standard therapy for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS); the outcomes of patients who relapse following HCT are dismal. HCT can suppress the progression of AML or MDS through a graft-vs-leukemia (GvL) effect, and in this manner, cure a subset of patients. In post-HCT relapse, agents with direct anti-leukemic activity, but which also enhance GvL, are of interest. High dose lenalidomide (50mg daily) had a promising response rate in relapsed AML (Blum et al JCO 2010), and has immunomodulatory properties that may be particularly effective in the post-HCT setting. Bortezomib has been shown to potentiate other chemotherapies and may augment GvL while limiting graft vs. host disease (GVHD). We studied increasing doses of bortezomib added to lenalidomide for patients with AML or MDS relapsing after HCT.