Overview

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

Status:
Terminated
Trial end date:
2007-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoosier Cancer Research Network
Collaborators:
Eli Lilly and Company
Walther Cancer Institute
Treatments:
Gemcitabine
Rituximab
Criteria
Inclusion Criteria:

- Biopsy-proven DLBCL which meet the criteria of any of the 4 subgroups

- Transformed DLBCL from a previous indolent NHL which meet the criteria of any of the 4
subgroups and have received at least one standard chemotherapy regimen for aggressive
NHL or a biopsy upon progression of disease has been obtained to confirm the presence
of DLBCL. The concomitant presence of a component of low grade lymphoma will NOT
exclude participation

- Measurable disease per Standardized Response Criteria for Non-Hodgkin's Lymphoma

- Prior gemcitabine therapy is allowed.

- Negative pregnancy test

Exclusion Criteria:

- No history of life-threatening reactions to rituximab.

- No history of gemcitabine intolerance; prior gemcitabine therapy is allowed.

- No history of malignancy in the last 5 years (basal cell carcinoma of the skin
excluded).

- No central nervous system or cerebrospinal fluid involvement

- No other investigational drugs received within 30 days prior to being registered for
protocol therapy.

- No active infections.

- No current breastfeeding