A Study of Participants With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Participants Who Take R-CHOP Only

NCT00451178 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2020-07-21

Study results available
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Summary

To compare R-CHOP plus enzastaurin versus R-CHOP for progression-free survival (PFS) time measured in participants with intermediate and/or high risk for diffuse large B-cell lymphoma (DLBCL) receiving first-line treatment.

Conditions

Interventions

DRUG

enzastaurin

1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years

DRUG

rituximab

375 milligrams per square meter (mg/m\^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles

DRUG

cyclophosphamide

750 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles

DRUG

doxorubicin

50 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles

DRUG

vincristine

1.4 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles

DRUG

prednisone

100 mg, oral, Days 1-5, six 21-day 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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2012-02-29
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00451178 on ClinicalTrials.gov