Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™
Public ClinicalTrials.gov record NCT03263026. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Enzastaurin Plus R-CHOP Versus R-CHOP in Treatment-Naive Subjects With High-Risk Diffuse Large B-Cell Lymphoma Who Possess the Novel Genomic Biomarker DGM1™
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, placebo-controlled phase 3 study planned to enroll approximately 235 treatment-naïve subjects with high-risk Diffuse Large B-Cell Lymphoma (DLBCL). Subjects were randomized 1:1 to R-CHOP plus enzastaurin or R-CHOP (plus placebo during induction). All subjects received up to 6 cycles (3 weeks per cycle) of treatment. PET/ CT was used to assess radiographic response at the end of treatment. Each subject's treatment assignment was unblinded after combination phase tumor response assessment. Subjects randomized to the enzastaurin arm who have a complete response (CR) or partial response (PR) (at investigator's discretion) by Lugano Classification had the opportunity to continue in the single-agent phase of the study and receive single-agent enzastaurin for up to 2 additional years.
Study identification
- NCT ID
- NCT03263026
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 256 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 19, 2018
- Primary completion
- Aug 10, 2022
- Completion
- Aug 10, 2022
- Last update posted
- Jan 22, 2025
2018 – 2022
United States locations
- U.S. sites
- 27
- U.S. states
- 17
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Oncology Specialties: Clearview Cancer Institute | Huntsville | Alabama | 35805 | — |
| University of Arizona | Tucson | Arizona | 85719 | — |
| Central Arkansas Radiation Therapy Institute | Little Rock | Arkansas | 72205 | — |
| Desert Hematology | Rancho Mirage | California | 92270 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Illinois CancerCare | Peoria | Illinois | 61615 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Norton Cancer Institute Oncology Practices - St. Matthews Location | Louisville | Kentucky | 40241 | — |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | — |
| Mercy Research | Springfield | Missouri | 65806 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Norris Cotton Cancer Center Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | — |
| Summit Medical Group | Morristown | New Jersey | 07960 | — |
| Atlantic Health System/ Morristown Meeical Center | Morristown | New Jersey | 07972 | — |
| New York Medical College | Hawthorne | New York | 10595 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | — |
| Hematology & Oncology Associates, Inc. | Canton | Ohio | 44708 | — |
| Tri-County Hematology & Oncology Associates, Inc. | Massillon | Ohio | 44646 | — |
| Toledo Clinic Cancer Centers | Toledo | Ohio | 43623 | — |
| University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center | Dallas | Texas | 75235 | — |
| Oncology Consultants: Memorial City | Houston | Texas | 77024 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Seattle Cancer Center Alliance | Seattle | Washington | 98109 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Vince Lombardi Cancer Center (Aurora St. Luke's Medical Center) | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03263026, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03263026 live on ClinicalTrials.gov.