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

Stopped early · Phase 2

Conditions studied: Lymphoma, B-Cell

In brief

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.

Key facts

Study ID

NCT00216164

Run by

Hoosier Cancer Research Network

People needed

8

Starts

2005-04-01

Expected to finish

2007-03-01

Last updated by the study team

2011-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Elkhart Clinic — Elkhart, Indiana, United States
• Oncology Hematology Associates of SW Indiana — Evansville, Indiana, United States
• Fort Wayne Oncology & Hematology, Inc — Fort Wayne, Indiana, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Quality Cancer Center (MCGOP) — Indianapolis, Indiana, United States
• Center for Cancer Care, Inc., P.C. — New Albany, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• AP&S Clinic — Terre Haute, Indiana, United States

Full record on ClinicalTrials.gov

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