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

NCT00216164 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2011-05-02

No results posted yet for this study

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.

Conditions

  • Lymphoma, B-Cell

Interventions

DRUG

Rituximab

Rituximab 375 mg/m2, day 1 of 21 day cycle

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2, days 1 and 8 of 21 day cycle

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Walther Cancer Institute

    collaborator OTHER

  • Hoosier Cancer Research Network

    lead OTHER

Principal Investigators

  • Michael Robertson, M.D. · Hoosier Oncology Group, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00216164 on ClinicalTrials.gov