Status:
TERMINATED
Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Eli Lilly and Company
Walther Cancer Institute
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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....
Detailed Description
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 chemother...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00216164
Start Date
April 1 2005
End Date
March 1 2007
Last Update
May 2 2011
Active Locations (9)
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1
Elkhart Clinic
Elkhart, Indiana, United States, 46515
2
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
3
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
4
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202