NCT00216164

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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 2, 2011

Status Verified

April 1, 2011

Enrollment Period

1.9 years

First QC Date

September 12, 2005

Last Update Submit

April 28, 2011

Conditions

Lymphoma, B-Cell

Keywords

Lymphoma

Outcome Measures

Primary Outcomes (1)

  • · Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.

    18 months

Secondary Outcomes (1)

  • · Evaluate toxicity, time to progression and overall survival.

    18 months

Study Arms (1)

1

EXPERIMENTAL

Rituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Drug: RituximabDrug: Gemcitabine

Interventions

RituximabDRUG

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

1
GemcitabineDRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Elkhart Clinic

Elkhart, Indiana, 46515, United States

Location

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, 47714, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, 46202, United States

Location

Center for Cancer Care, Inc., P.C.

New Albany, Indiana, 47150, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

AP&S Clinic

Terre Haute, Indiana, 47804, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma

Interventions

RituximabGemcitabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Michael Robertson, M.D.

    Hoosier Oncology Group, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

April 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

May 2, 2011

Record last verified: 2011-04

Locations

US(9)