Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center
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 < 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 groupSponsors and collaborators
Beth Israel Deaconess Medical Center
Lead sponsor
Genmab
Collaborator
Source ClinicalTrials.gov