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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
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 66 to confirmed 49 · Site details revised at 18 of 18 sitesv22Show 2 more changesShow less
Enrollment target: estimated 66 to confirmed 49
Site details revised at 18 of 18 sites
MinorRe-verified, no change to tracked fieldsv21
MinorPrimary and study completion dates: Jan 15, 2024 to Jan 25, 2024Eligibility criteria expanded, about 138 wordsv20Show 1 more changeShow less
Minor2 versionsRe-verified since Feb 3, 2023, no change to tracked fieldsv18-v19
MinorSite details revised at 3 of 18 sitesv17
MinorRe-verified, no change to tracked fieldsv16
MinorStudy sites: 19 to 18v15
MinorSite details revised at 1 of 19 sitesv14
MinorSite details revised at 2 of 19 sitesv13
MinorSite details revised at 1 of 19 sitesv12
MinorSite details revised at 2 of 19 sitesv11
MinorSite details revised at 1 of 19 sitesv10
MinorSite details revised at 1 of 19 sitesv9
MinorSite details revised at 1 of 19 sitesv8
MinorSite details revised at 1 of 19 sitesv7
MinorStudy sites: 21 to 19v6
MinorSite details revised at 1 of 21 sitesv5
MinorSite details revised at 1 of 21 sitesv4
NotablePrimary endpoints revised (2)Primary and study completion dates: Dec 11, 2023 to Jan 15, 2024 · Eligibility criteria expanded, about 274 words · Secondary endpoints: 12 to 5 · 1 morev3Show 4 more changesShow less
Primary and study completion dates: Dec 11, 2023 to Jan 15, 2024
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 22 to 21 · Start date changed from estimate of Mar 14, 2022 to Mar 10, 2022 · Eligibility criteria shortened, about 2 wordsv2Show 3 more changesShow less
Study sites: 22 to 21
Start date changed from estimate of Mar 14, 2022 to Mar 10, 2022
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.