Phase 3 Study Comparing Epcoritamab to Chemotherapy in Patients with Difficult-to-Treat Diffuse Large B-cell Lymphoma (DLBCL)
Sponsor: Genmab
ClinicalTrials ID:NCT04628494
This clinical trial is testing whether the drug epcoritamab is safe and effective for patients with Diffuse Large B-cell Lymphoma (DLBCL) that has not responded to previous treatments or has returned. Participants will be randomly assigned to receive either epcoritamab or a standard chemotherapy regimen chosen by their doctor.
Patient Parameters
| Parameter | Options |
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Program Overview
The trial aims to determine if epcoritamab, also known as EPKINLY™ and GEN3013, is a safe and effective treatment for patients with DLBCL that has not responded to previous treatments or has returned. Participants will be randomly assigned to receive either epcoritamab or a standard chemotherapy regimen chosen by their doctor. Epcoritamab is given as an injection under the skin, while the chemotherapy is given through an IV. The study will last up to 5 years, with participants undergoing a screening period, treatment, and follow-up until death. The treatment schedule varies depending on the group assigned, with epcoritamab given weekly at first, then less frequently, and chemotherapy given in cycles over several months.
Description
This is a global phase 3 study to compare the effectiveness of epcoritamab with standard chemotherapy in patients with relapsed or refractory DLBCL who cannot undergo high-dose chemotherapy and stem cell transplant. The study will measure overall survival and progression-free survival to determine which treatment is more effective. Participants will be randomly assigned to receive either epcoritamab or a standard chemotherapy regimen. Epcoritamab is administered as an injection under the skin, while chemotherapy is given through an IV. The study will last up to 5 years, with participants undergoing a screening period, treatment, and follow-up until death. The treatment schedule varies depending on the group assigned, with epcoritamab given weekly at first, then less frequently, and chemotherapy given in cycles over several months.
Eligibility Criteria
Inclusion Criteria
- Have DLBCL that has returned or not responded to at least one previous treatment, including a combination with an anti-CD20 antibody.
- Have one of the following types of DLBCL: not otherwise specified, "double-hit" or "triple-hit" DLBCL, FL Grade 3B, or T-cell/histiocyte-rich large B-cell lymphoma.
- Have a performance status score of 0-2, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have failed or are not eligible for high-dose chemotherapy and stem cell transplant.
- Have detectable disease by PET scan and measurable by CT or MRI.
- Have acceptable kidney and liver function.
- Have a life expectancy of more than 2 months on standard treatment.
Exclusion Criteria
- Have a primary CNS tumor or known CNS involvement.
- Have previously received a bispecific antibody targeting CD3 and CD20.
- Have had major surgery within 4 weeks before starting the study.
- Have received chemotherapy or other cancer treatments (except CD20 antibodies) within 4 weeks or 5 half-lives before starting the study.
- Have taken an investigational drug within 4 weeks or 5 half-lives before starting the study.
- Have had a stem cell transplant within 100 days before starting the study.
- Have received CAR-T therapy within 100 days before starting the study.
- Have a seizure disorder requiring medication.
- Have significant heart disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Indiana Blood and Marrow Transplantation | 46237 | Indianapolis | Indiana |
| Community Health Network Cancer Center North | 46250 | Indianapolis | Indiana |
| University of Kentucky Markey Cancer Center | 40536 | Lexington | Kentucky |
| Henry Ford Health System | 49201 | Jackson | Michigan |
| MMCORC Attn Delaney Anderson | 55416 | Saint Louis Park | Minnesota |
| MD Anderson Cancer Center at Cooper | 08103 | Camden | New Jersey |
| Wake Forest Baptist Health | 27157 | Winston-Salem | North Carolina |
| The Christ Hospital Cancer Center | 45229 | Cincinnati | Ohio |
| TriHealth Cancer Institute- Good Samaritan Hospital | 45247 | Cincinnati | Ohio |
| Brooke Army Medical Center | 78234 | Fort Sam Houston | Texas |
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