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A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China
Sponsor: Genmab
Summary
The purpose of this Chinese sub-study trial is to find out if epcoritamab, also known as EPKINLY™ and GEN3013, is safe and works well as treatment for participants with DLBCL that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin \[R-GemOx\], or bendamustine + rituximab \[BR\]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT). Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously. Trial details include: The trial duration will be up to 5 years after last participant is randomized. All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death. The estimated trial duration for an individual participant depends upon the treatment arm assigned: Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events. Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either: R-GemOx: On Day 1 (or Day 1 \& Day 2), and Day 15 (or Day 15 \& Day 16) every 28 days, for up to 4 months; or BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.
Official title: A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2022-10-08
Completion Date
2028-06-14
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Epcoritamab
Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.
Investigator's Choice Chemotherapy
Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.
Locations (23)
Affiliated Hospital of Hebei University
Baoding, China
Beijing Cancer Hospital
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
West China Hospital, Sichuan University
Chengdu, China
The Second Hospital of Dalian Medical University
Dalian, China
Guangdong Provincial Peoples Hospital
Guandong, China
Guangxi Medical University Affiliated Tumor Hospital
Guangxi, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Hubei Cancer Hospital
Hubei, China
Hunan Cancer Hospital
Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Qingdao Central Hospital
Qingdao, China
Shanxi Provincial Cancer Hospital
Shanxi, China
Shengjing Hospital of China Medical University
Shenyang, China
Shenzhen Peoples Hospital
Shenzhen, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Yantai Yuhuangding Hospital
Yantai, China
Henan Cancer Hospital
Zhengzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhenjiang, China