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 safety and toxicity of epcoritamab as a monotherapy and when combined with standard of care therapy [Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or Rituximab and lenali...
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Location | Status | Site Contact Details |
---|---|---|
Location The Fifth Medical Center of PLA General Hospital, Beijing, Beijing, 100071 | Status Not Available | Site Contact Details |
Location Peking University Third Hospital, Beijing, Beijing, 100191 | Status Not Available | Site Contact Details |
Location Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001 | Status Not Available | Site Contact Details |
Location Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060 | Status Not Available | Site Contact Details |
Location Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080 | Status Not Available | Site Contact Details |
Location Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, 510515 | Status Not Available | Site Contact Details |
Location Henan Cancer Hospital, Zhengzhou, Henan, 450008 | Status Not Available | Site Contact Details |
Location Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc, Wuhan, Hubei, 430022 | Status Not Available | Site Contact Details |
Location Hunan Cancer Hospital, Changsha, Hunan, 410006 | Status Not Available | Site Contact Details |
Location The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006 | Status Not Available | Site Contact Details |
Location The Affiliated Hospital of Xuzhou Medical College, Xuzhou, Jiangsu, 221006 | Status Not Available | Site Contact Details |
Location The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006 | Status Not Available | Site Contact Details |
Location Jiangxi Provincial Cancer Hospital, Nanchang, Jiangxi, 330029 | Status Not Available | Site Contact Details |
Location Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, 200065 | Status Not Available | Site Contact Details |
Location West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 | Status Not Available | Site Contact Details |
Location Tianjin Cancer Hospital, Tianjin, Tianjin, 300000 | Status Not Available | Site Contact Details |
Location The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003 | Status Not Available | Site Contact Details |
Location Zhejiang Cancer hospital, Hangzhou, Zhejiang, 310022 | Status Not Available | Site Contact Details |
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 safety and toxicity of epcoritamab as a monotherapy and when combined with standard of care therapy [Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or Rituximab and lenalidomide (R2)] in adult participants in China with B-Cell Non-Hodgkin Lymphoma. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of B-Cell Non-Hodgkin Lymphoma. Study doctors put the participants in groups called treatment arms. A monotherapy of epcoritamab and two different combination of epcoritamab with standard of care therapy (R-CHOP or R2) will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. Approximately 66 adult participants with B-Cell Non-Hodgkin Lymphoma will be enrolled in the study in approximately 21 sites in China. In the monotherapy arm (Cohort 1), participants will receive subcutaneous epcoritamab in 28-day cycles. In the combination arms (Cohorts 2 and 3), participants in Cohort 2 will receive subcutaneous epcoritamab with standard of care therapy (R-CHOP) in 21-day cycles followed by 28-day cycles, participants in Cohort 3 will receive subcutaneous epcoritamab with standard of care therapy (R2) in 28-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.
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Best Overall Response (BOR)
Time Frame: Up to Approximately 5 Years
Cohort 1 Part 1, Cohort 2, and Cohort 3: Number of Incidence of Dose-Limiting Toxicities (DLT)
Time Frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Percentage of Participants with Complete Remission (CR)
Time Frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Number of Participants with Progression-free survival (PFS)
Time Frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Overall survival (OS)
Time Frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Duration of response (DOR)
Time Frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Time-to-response (TTR)
Time Frame: Up to Approximately 5 Years
Interventions:
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