Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Overview

Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic actions of several chemotherapy agents by enhancing sensitivity of tumor cells to chemotherapy-induced apoptosis. Gemcitabine, a nucleoside analog that is used in several other malignancies, has shown very promising activity in patients with refractory Hodgkin's disease and low-grade NHL. The combination of rituximab and gemcitabine may have synergistic cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved response rates and demonstrable clinical benefit. This trial will investigate the efficacy the combination of rituximab and gemcitabine in treating patients with relapsed or refractory DLBCL.

OUTLINE: This is a multi-center study. * Rituximab 375 mg/m2 day 1 of 21 day cycle * Gemcitabine 1000 mg/m2 days 1 and 8 of 21 day cycle Subgroup 1. Relapsed after responding to first line chemotherapy, who are not candidates for salvage high-dose chemotherapy. Subgroup 2. Failure to achieve a complete response or relapsed after responding to salvage chemotherapy (any number of salvage regimens allowed), who are not candidates for high-dose chemotherapy. Subgroup 3. Refractory to first line chemotherapy and/or 1 (one) salvage chemotherapy regimen. Subgroup 4. Progression after high-dose chemotherapy. Patients with progressive disease within 3 months of high-dose chemotherapy are not allowed. Performance Status: ECOG performance status 0, 1, 2 Life expectancy: Not specified Hematopoietic:· * ANC ≥ 1,000/mm3· * Platelets ≥ 100,000/mm3 Hepatic:· * Total bilirubin ≤ 2.0 x ULN· * ALT and AST ≤ 3 x ULN unless lymphoma involves the liver on CT scan then AST and ALT can be \< 5 x ULN Renal:· * Serum creatinine ≤ 2.0 mg/dl (except for patients on dialysis) Cardiovascular:· * Not specified Pulmonary:· * Not specified