Spots Global Cancer Trial Database for A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma
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Trial Identification
Brief Title: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma
Official Title: Phase 1b/2, Open-Label Trial to Evaluate Safety and Preliminary Efficacy of Epcoritamab As Monotherapy or Combined With Standard-of-Care Therapies in Chinese Subjects With B-Cell Non-Hodgkin Lymphoma
Study ID: NCT05201248
Conditions
Study Description
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). 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Fifth Medical Center of PLA General Hospital /ID# 230520, Beijing, Beijing, China
Peking University Third Hospital /ID# 228138, Beijing, Beijing, China
Fujian Medical University Union Hospital /ID# 231890, Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center /ID# 228033, Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital /ID# 228028, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 227916, Guangzhou, Guangdong, China
Henan Cancer Hospital /ID# 228772, Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221, Wuhan, Hubei, China
Hunan Cancer Hospital /ID# 231859, Changsha, Hunan, China
The First Affiliated Hospital of Soochow University /ID# 228024, Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College /ID# 228774, Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 228771, Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital /ID# 231944, Nanchang, Jiangxi, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724, Shanghai, Shanghai, China
West China Hospital, Sichuan University /ID# 231434, Chengdu, Sichuan, China
Tianjin Cancer Hospital /ID# 228135, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154, Hangzhou, Zhejiang, China
Zhejiang Cancer hospital /ID# 228776, Hangzhou, Zhejiang, China
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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