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NCT05578976 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 3 study of Diffuse Large B Cell Lymphoma, sponsored by Genmab.
- Active
- Registry status
- Phase 3
- Development phase
- 900
- Enrollment target
- 20
- Study locations
NCT05578976: Active Phase 3 study of Diffuse Large B Cell Lymphoma, sponsored by Genmab.
NCT05578976 is a Phase 3 study of Diffuse Large B Cell Lymphoma that is active but no longer recruiting, run by Genmab. The registered enrollment target is 900 participants, above the 211-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (327% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05578976, a Phase 3 study of Diffuse Large B Cell Lymphoma, is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 900 participants
- Enrollment target
- 20
- Study locations
Study Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Primary Outcome
PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Epcoritamab
- DRUG Rituximab
- DRUG Vincristine
Study Locations (20)
California
- CBCC Global Research, Inc. /ID# 262037 - Bakersfield
- Alta Bates Summit Medical Center for Research /ID# 229427 - Berkeley
- Orange Coast Memorial Medical Center /ID# 229632 - Fountain Valley
- Providence - St. Jude Medical Center /ID# 262042 - Fullerton
- Saddleback Memorial Medical Center /ID# 229631 - Laguna Hills
- Long Beach Memorial Medical Ct /ID# 228996 - Long Beach
- Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032 - Los Alamitos
- University of Southern California /ID# 225443 - Los Angeles
- University of California, Los Angeles /ID# 226887 - Los Angeles
Florida
- Cancer Specialists of North Florida /ID# 226826 - Jacksonville
- Ocala Oncology Florida Cancer Affiliates - Main /ID# 262785 - Ocala
- Orlando Health Cancer Institute /ID# 232626 - Orlando
Illinois
- University of Illinois at Chicago /ID# 226889 - Chicago
- Southern IL Univ School of Med /ID# 228999 - Springfield
- Springfield Clinic Main Campus /ID# 262584 - Springfield
Arizona
- University of Arizona Cancer Center - North Campus /ID# 227463 - Tucson
- Yuma Regional Medical Center /ID# 261527 - Yuma
Arkansas
- University of Arkansas for Medical Sciences /ID# 225703 - Little Rock
Colorado
- Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618 - Aurora
Hawaii
- Straub Medical Center /ID# 229464 - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2023-02-08 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What the registry record for NCT05578976 still lists
NCT05578976 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 211-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (327% higher).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05578976 names 20 study sites across 7 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05578976 about?
NCT05578976 is a clinical study titled "A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)". B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin h...
What is the current status of trial NCT05578976?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 900 participants. The study started on 2023-02-08. Estimated completion is 2029-12.
What conditions does trial NCT05578976 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT05578976?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Epcoritamab (DRUG), Rituximab (DRUG), Vincristine (DRUG).
Who is sponsoring clinical trial NCT05578976?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05578976 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05578976's enrollment target sits among peer trials
900 5th of 114 higher than 110 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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