Phase 2 study of gemcitabine in combination with rituximab in patients with recurrent or refractory Hodgkin lymphoma

BACKGROUND. The management of recurrent or refractory Hodgkin lymphoma (HL) remains challenging. The objective of this phase <= 2 trial was to investigate the activity of gemcitabine in combination with rituximab in patients with recurring or refractory HL. METHODS. Patients were considered eligible if they had recurring or refractory HL, had received >= 2 prior chemotherapy regimens, had an Eastern Cooperative Oncology Group (ECOG) performance status <= 2, and had adequate organ function. Rituximab was administered at a dose of 375 mg/m(2) intravenously every week for 6 weeks. Gemcitabine was administered at a dose of 1250 mg/m(2) intravenously on Days I and 8, with a week of rest on Day 15 of 21-day cycles in outpatient settings. Response was assessed after 2 cycles of gemcitabine, and those patients who demonstrated a response continued to receive a maximum of 4 additional courses of gemicitabine. RESULTS. Thirty-three patients received the study drugs. The median age of patients was 32 years (range, 19-81 years), and 55% of the patients previously under-went autologous stem cell transplantation. Grade 3 or 4 (graded according to the National Cancer Center Institute Common Toxicity Criteria [version 2.0]) toxic effects included neutropenia (36%) and thrombocytopenia (15%). Objective responses occurred in 16 patients (48%). Responses were observed regardless of CD20 positivity in tumor cells. The rnedian duration of failure-free survival was 2.7 months (range, 0.9-18.3 months). Seven patients (21%) eventually proceeded to either autologous (n = 2) or allogeneic (n = 5) stem cell transplantation. CONCLUSIONS. Combination therapy with gemcitabine and rituximab is active in previously treated patients with recurrent or refractory HL. The favorable safety profile and the ease of its administration in outpatient settings warrant investigating it further in combination with other active drugs.