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)
This is a prospective, phase 2, single arm, open label trial investigating epcoritamab in participants with follicular lymphoma (FL) who have failed to achieve a complete response after frontline therapy. Epcoritamab is a bispecific antibody, a synthetic protein that activates the immune system to target cancer cells. The U.S. Food and Drug Administration (FDA) has not approved epcoritamab for follicular lymphoma but it has been approved for other uses. The research study procedures include screening for eligibility, treatment study visits, questionnaires, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, electrocardiograms, blood tests, and bone marrow biopsies. Participants will receive treatment for up to 12 cycles and will be followed for 2 years. It is expected that about 35 people will take part in this research study. Genmab, Inc. is funding this research study by providing the study drug, Epcoritamab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Humanized IgG1 bispecific antibody, 5 or 60 mL vial, via subcutaneous (under the skin) injection per protocol.
Stanford
Stanford, California, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGComplete 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.
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.
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.
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 years
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 years
Median Duration of Response (DOR)
DOR estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per Lugano Response Criteria, until the first date that recurrent or progressive disease is objectively documented. Participants without progressive disease are censored at the date of last disease assessment.
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Time frame: Observation period up to approximately 12 cycles (1 cycle being 28 days)
Median Duration of Complete Response
Duration of complete response estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR per Lugano Response Criteria, until the first date that recurrent or progressive disease is objectively documented. Participants without progressive disease are censored at the date of last disease assessment.
Time frame: Observation period up to approximately 12 cycles (1 cycle being 28 days)
Rate of Progression of Disease (PD) within 24 months (POD 24)
The POD24 was defined as the proportion of participants achieving progression disease (PD) based on Lugano Response Criteria (Adapted from Cheson, 2014) within 24 months.
Time frame: Up to 24 months
Grade 4-5 Treatment-related Toxicity Rate
All grade 4-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Time frame: 12 months (12 cycles of treatment, each cycle is 28 days)
Rate of Disappearance of ctDNA
ctDNA assesment done using established method is the proportion of treated participants experiencing disappearance of ctDNA.
Time frame: 24 months