Phase I study of oral azacitidine plus salvage chemotherapy in relapsed/refractory diffuse large B-cell lymphoma.

Salvage chemotherapy and autologous stem cell transplantation (ASCT) offer the opportunity to cure eligible patients with relapsed diffuse large B-cell lymphoma (DLBCL). Epigenetic alterations such as aberrant DNA methylation patterns have been linked to chemotherapy resistance in DLBCL. Oral Azacitadine (AZA) is a hypomethylating agent that inhibits DNA methyltransferase and has provided evidence of chemotherapy sensitization in DLBCL. In this phase I trial the safety and feasibility of two dose levels of AZA were investigated in combination with standard cytotoxic chemotherapy rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in relapsed DLBCL patients who were candidates for ASCT.