Non Hodgkin Lymphoma Clinical Trial
A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) or R/R follicular lymphoma (FL). Adverse events will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R FL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 80 adult participants with R/R DLBCL and R/R FL will be enrolled in the study in approximately 40 in the United States of America.
Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, 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.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Follicular Lymphoma (FL) grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative pathology report:
Participants with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
Relapsed or refractory disease and previously treated with at least 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy.
Must have 1 or more measurable disease sites:
Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm (or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm) AND FDG positron emission tomography (PET) scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
FDG-nonavid lymphomas: Measurable disease with CT (or MRI) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm.
Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Adequate organ function.
Exclusion Criteria:
- Central nervous system (CNS) involvement.
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There are 41 Locations for this study
Little Rock Arkansas, 72205, United States
Fountain Valley California, 92708, United States More Info
Boulder Colorado, 80303, United States
Stamford Connecticut, 06902, United States
Miami Beach Florida, 33140, United States
Pembroke Pines Florida, 33028, United States
Weston Florida, 33331, United States
Chicago Illinois, 60607, United States
Niles Illinois, 60714, United States
Indianapolis Indiana, 46237, United States
Bethesda Maryland, 20817, United States More Info
Columbia Maryland, 21044, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Ypsilanti Michigan, 48197, United States
Chesterfield Missouri, 63017, United States
Lebanon New Hampshire, 03756, United States
Morristown New Jersey, 07960, United States
Albuquerque New Mexico, 87102, United States
New York New York, 10021, United States
Greenville North Carolina, 27834, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45236, United States
Toledo Ohio, 43623, United States
Oklahoma City Oklahoma, 73104, United States
Eugene Oregon, 97401, United States
Allentown Pennsylvania, 18103, United States More Info
Hershey Pennsylvania, 17033, United States
Pittsburgh Pennsylvania, 15232, United States
York Pennsylvania, 17403, United States
Greenville South Carolina, 29605, United States
Austin Texas, 78705, United States
Dallas Texas, 75390, United States
San Antonio Texas, 78240, United States
Tyler Texas, 75702, United States
Gainesville Virginia, 20155, United States
Tacoma Washington, 98405, United States
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