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

Study Identifier
M21-103
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
  • Study Drug
  • Epcoritamab
  • Cyclophosphamide
  • Rituximab
  • Doxorubicin
  • Vincristine
  • Prednisone
  • Lenalidomide
  • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    The Fifth Medical Center of PLA General Hospital /ID# 230520
    Beijing, Beijing Municipality, China, 100071
    Status
    Not applicable
    Location
    Peking University Third Hospital /ID# 228138
    Beijing, Beijing Municipality, China, 100191
    Status
    Not applicable
    Location
    Fujian Medical University Union Hospital /ID# 231890
    Fuzhou, Fujian, China, 350001
    Status
    Not applicable
    Location
    Sun Yat-Sen University Cancer Center /ID# 228033
    Guangzhou, Guangdong, China, 510060
    Status
    Not applicable
    Location
    Guangdong Provincial People's Hospital /ID# 228028
    Guangzhou, Guangdong, China, 510080
    Status
    Not applicable
    Location
    Nanfang Hospital of Southern Medical University /ID# 227916
    Guangzhou, Guangdong, China, 510515
    Status
    Not applicable
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