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

April 28, 2011 updated by: Hoosier Cancer Research Network

Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Hoosier Oncology Group LYM03-64

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 chemotherapy, who are not candidates for salvage high-dose chemotherapy.

Subgroup 2. Failure to achieve a complete response or relapsed after responding to salvage chemotherapy (any number of salvage regimens allowed), who are not candidates for high-dose chemotherapy.

Subgroup 3. Refractory to first line chemotherapy and/or 1 (one) salvage chemotherapy regimen.

Subgroup 4. Progression after high-dose chemotherapy. Patients with progressive disease within 3 months of high-dose chemotherapy are not allowed.

Performance Status: ECOG performance status 0, 1, 2

Life expectancy: Not specified

Hematopoietic:·

  • ANC ≥ 1,000/mm3·
  • Platelets ≥ 100,000/mm3

Hepatic:·

  • Total bilirubin ≤ 2.0 x ULN·
  • ALT and AST ≤ 3 x ULN unless lymphoma involves the liver on CT scan then AST and ALT can be < 5 x ULN

Renal:·

  • Serum creatinine ≤ 2.0 mg/dl (except for patients on dialysis)

Cardiovascular:·

  • Not specified

Pulmonary:·

  • Not specified

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart Clinic
      • Evansville, Indiana, United States, 47714
        • Oncology Hematology Associates of SW Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Fort Wayne Oncology & Hematology, Inc
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Quality Cancer Center (MCGOP)
      • New Albany, Indiana, United States, 47150
        • Center for Cancer Care, Inc., P.C.
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
      • Terre Haute, Indiana, United States, 47802
        • Providence Medical Group
      • Terre Haute, Indiana, United States, 47804
        • AP&S Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Rituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
· Evaluate toxicity, time to progression and overall survival.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoosier Cancer Research Network

Collaborators

Eli Lilly and Company
Walther Cancer Institute

Investigators

  • Study Chair: Michael Robertson, M.D., Hoosier Oncology Group, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOG LYM03-64

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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