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
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
-
375 milligrams per square meter (mg/m\^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles
- DRUG
-
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
-
100 mg, oral, Days 1-5, six 21-day cycles
Sponsors & Collaborators
- lead INDUSTRY
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
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