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Chemotherapy for Participants With Lymphoma

NCT00436280 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-08-06

Study results available
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Summary

The primary purpose of this study is to help answer the following research questions:

* To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer.
* To assess for any side effects that might be associated with enzastaurin and R-GEMOX .
* To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body.
* To look at the level of enzastaurin in the body and how long it remains.

Conditions

  • Lymphoma, Large Cell, Diffuse

Interventions

DRUG

enzastaurin

1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years

DRUG

gemcitabine

1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles

DRUG

rituximab

375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles

DRUG

oxaliplatin

100 mg/m², IV, once every two weeks, four to eight 2 week cycles

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-11-30
Completion
2012-11-30

Countries

  • France
  • Germany
  • Russia

Study Locations

More Related Trials

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 NCT00436280 on ClinicalTrials.gov