Health Trials

About this trial

This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment.

The name of the study drug in this research study is:

-Epcoritamab (a type of antibody)

Eligibility criteria

Qualifiers

Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of diagnosis. All degrees of CD20 positivity will be accepted. Composite high-grade lymphoma will be excluded.

Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm and short axis >1.0 cm and Deauville ≥ 4 seen on baseline PET/CT

Stage III/IV at initial diagnosis

1 prior line (at least 3 cycles) of systemic "upfront" or first-line therapy consisting of anti-CD20 antibody (e.g. obinutuzumab or rituximab) combined with chemotherapy (e.g. bendamustine, CHOP, CVP, or lenalidomide). Rituximab monotherapy, rituximab plus radiation, or radiation alone is not sufficient.

Disqualifiers

Use of investigational agents incorporated into prior induction therapy

Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment

Uncontrolled underlying cardiac conditions including but not limited to congestive heart failure grade III or IV (by NYHA) or EF <45%, unstable angina pectoris, acute myocardial infarction &lt; 6 months, cardiac arrhythmia

History of uncontrolled neurologic condition including but not limited to seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis

Trial design

Treatments tested in this trial

  • Epcoritamab

Treatment groups

35 Participants
are divided into 1 treatment group

Locations

3
Stanford94305, StanfordCalifornia, United States
Beth Israel Deaconess Medical Center02215, BostonMassachusetts, United States
Icahn School of Medicine at Mount Sinai10029, New YorkNew York, United States

Sponsors and collaborators

Beth Israel Deaconess Medical Center

Lead sponsor

Genmab

Collaborator

Source ClinicalTrials.gov