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

Part of paid clinical trials in Elkhart, Indiana.

Sponsor
Hoosier Cancer Research Network
Study ID
NCT00216164
Phase
PHASE2
Status
Terminated

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375 mg/m2, day 1 of 21 day cycle
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2, days 1 and 8 of 21 day cycle

Study Details

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 Dates

Start date
Apr 30, 2005
Status verified
Apr 2011
Primary completion
Mar 31, 2007
Completion
Mar 31, 2007

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Rituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Primary Outcome Measure

· Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL. [ Time Frame: 18 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Elkhart ClinicElkhartIndiana46515-
Oncology Hematology Associates of SW IndianaEvansvilleIndiana47714-
Fort Wayne Oncology & Hematology, IncFort WayneIndiana46815-
Indiana University Cancer CenterIndianapolisIndiana46202-
Quality Cancer Center (MCGOP)IndianapolisIndiana46202-
Center for Cancer Care, Inc., P.C.New AlbanyIndiana47150-
Northern Indiana Cancer Research ConsortiumSouth BendIndiana46601-
AP&S ClinicTerre HauteIndiana47804-
Providence Medical GroupTerre HauteIndiana47802-

Find similar trials in Elkhart, IN

By research site
Elkhart Clinic· Elkhart, INOncology Hematology Associates of SW Indiana· Evansville, INFort Wayne Oncology & Hematology, Inc· Fort Wayne, INIndiana University Cancer Center· Indianapolis, INQuality Cancer Center (MCGOP)· Indianapolis, INCenter for Cancer Care, Inc., P.C.· New Albany, IN

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