At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed DLBCL (World Health Organization classification) with pathology review at investigational site prior to enrollment
- ✓No prior chemotherapy
- ✓International Prognostic Index (IPI) score ≥2 at time of original diagnosis
- ✓ECOG performance status 0, 1, or 2
- ✕Prior history of indolent lymphoma or follicular Grade 3 lymphoma
- ✕Receipt of unapproved investigational drug within 30 days prior to enrollment (excluding enzastaurin)
- ✕Concurrent administration of other systemic anticancer therapy
- ✕Pregnancy or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Phase 2 Study of R-CHOP Plus Enzastaurin Versus R-CHOP in the First-Line Treatment of Patients With Intermediate and High-Risk Diffuse Large B-Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating enzastaurin, rituximab, and 4 other interventions for Lymphoma. Completed, enrolled 101 participants across 25 sites.
Detailed 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.
Study Details
Timeline
Interventions
1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years
375 milligrams per square meter (mg/m\^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles
750 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
50 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
1.4 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
100 mg, oral, Days 1-5, six 21-day cycles