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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Epcoritamab
DrugHumanized IgG1 bispecific antibody, 5 or 60 mL vial, via subcutaneous (under the skin) injection per protocol.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: EpcoritamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Response Rate (CRR)
The CRR was defined as the proportion of participants achieving complete response (CR) based on Lugano Response Criteria (Adapted from Cheson, 2014).
Time frame
CRR expected to be observed up to 12 months.Secondary outcomes
1
Overall Response Rate (ORR)
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on Lugano Response Criteria (Adapted from Cheson, 2014).
Time frame
ORR expected to be observed up to 12 months.2
Median Progression-Free Survival (PFS)
Progression-free survival based on the Kaplan-Meier method is defined as the duration between registration and documented disease progression (PD) or death, or is censored at time of last disease assessment.
Time frame
Survival collected during all visits through 24 months then every 6 months through 5 years.3
Median Overall Survival (OS)
Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Time frame
Survival observed up to 5 years4
Median Time to Next Treatment (TTNT)
TTNT estimated using the Kaplan Meier method is defined as the time from registration until date of initiation of next line of treatment.
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
Genmab
Collaborator
Source ClinicalTrials.gov