NCT04542824 - Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 20, 2020

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions

Diffuse Large B Cell LymphomaHigh-grade B-cell LymphomaPrimary Mediastinal Large B Cell LymphomaFollicular LymphomaMarginal Zone LymphomaSmall Lymphocytic Lymphoma

Interventions

BIOLOGICAL

Epcoritamab (monotherapy)

Epcoritamab will be administered subcutaneously in cycles of 4 weeks (i.e. 28 days)

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered in combination with the respective SOC chemotherapy followed by epcoritamab monotherapy.

DRUG

Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone

21-day cycles

DRUG

Gemcitabine and oxaliplatin

28-day cycles

BIOLOGICAL

Epcoritamab (maintenance)

28-day cycle for Cycle 1 and then 56-day cycle from Cycle 2 through 13

DRUG

Rituximab and lenalidomide

28-day cycles.

Trial Locations (15)

980-8577

Tohoku University Hoaspital, Sendai

Unknown

Aichi Cancer Center Hospital, Aichi

NHO Nagoya Medical Center, Aichi

National Cancer Center Hospital East, Chiba

Matsuyama Red Cross Hospital, Ehime

National Hospital Organization Kyushu Cancer Center, Fukuoka

Fukushima Medical University Hospital, Fukushima

Kagoshima University Hospital, Kagoshima

Kyoto University Hospital, Kyoto

Kindai University Hospital, Osaka

Osaka University Hospital, Osaka

Cancer Institute Hospital of JFCR, Tokyo

National Cancer Center Hospital, Tokyo

Tokyo Medical University Hospital, Tokyo

Yamagata University Hospital, Yamagata