Status:
RECRUITING
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Genmab
Collaborating Sponsors:
AbbVie
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lena...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group Performance status score of 0 to 2.
- Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.
- Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.
- Participant must meet at least 1 of the following criteria:
- Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to high-dose therapy (HDT)-ASCT.
- Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.
- Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:
- Unable to receive CAR-T therapy due to fitness and/or comorbidity.
- Lymphocyte apheresis failure.
- Unwilling to receive CAR-T therapy.
- Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.
- Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.
- Must have measurable disease.
- Life expectancy \> 3 months on standard of care treatment at the time of enrolling in the study
Exclusion
- Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
- History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).
- Documented refractoriness to lenalidomide.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06508658
Start Date
August 13 2024
End Date
January 1 2028
Last Update
January 7 2026
Active Locations (177)
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1
City of Hope National Medical Center /ID# 273338
Duarte, California, United States, 91010
2
Valkyrie Clinical Trials /ID# 269935
Los Angeles, California, United States, 90067
3
Desert Regional Medical Center /ID# 272437
Palm Springs, California, United States, 92262
4
Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823
Golden, Colorado, United States, 80401