Outpatient Epcoritamab in Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The purpose of this study is to measure the efficacy of the study drug, epcoritamab, in participants with relapsed/refractory large B-cell lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
No prior systemic antineoplastic therapy for large B-cell lymphoma.
Score of "frail" or "unfit" on Fondazione Italiana Linfomi simplified Geriatric Assessment (FIL sGA) (Appendix E).
Relapsed or refractory disease treated with 1 prior systemic antineoplastic line of therapy that includes an anti-CD20 monoclonal antibody plus an anthracycline and/or an alkylating agent. Patients who have received more than 1 prior systemic antineoplastic line of therapy are not eligible.
Not a candidate for high dose chemotherapy and autologous stem cell transplant per the treating investigator, or patient refusal of high dose chemotherapy and autologous transplant.
Disqualifiers
Participant must not have used an investigational drug or approved systemic lymphoma therapy within 28 days preceding the first dose of study drug. Steroids for lymphoma disease control are permitted but must be stopped at least 7 days prior to the first dose of study drug.
Participants must not have received prior CD20/CD3 bispecific antibody.
Participants must not have received prior autologous or allogeneic stem cell transplant.
Participants must not have received prior anti-CD19 CAR T-cell therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Epcoritamab
DrugBispecific IgG1 antibody
Rituximab combined with cyclophosphamide, vincristine, and prednisone
DrugEpco-R-CVP
Rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone
DrugEpco-R-CHOP
Rituximab combined with polatuzumab, cyclophosphamide, doxorubicin, and prednisone
DrugEpco-pola-R-CHP
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: First LineExperimental treatment 4 interventions
Group B: Second LineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Response Rate (CRR) in first line cohort
The CRR is defined as the proportion of subjects achieving an objective response of complete response (CR) according to the Lugano Classification, prior to start of another non-study anticancer therapy. CRR is based on the best overall response. CRR will be reported as a proportion, exact binomial confidence interval, and assessed using an exact binomial test.
Time frame
Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 12 months after initial dose of study treatment.2
12-month progression free survival (PFS) in second line cohort
The time from registration to the earlier of progression or death due to any cause and will be defined as the percent of patients alive and progression-free at 12 months. Participants alive without disease progression are censored at date of last disease evaluation.
Time frame
Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 12 months after initial dose of study treatment.Secondary outcomes
1
12-month progression free survival (PFS) in first line cohort
PFS is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. The 12-month PFS rate will be reported as a proportion, exact binomial confidence interval, and assessed using an exact binomial test
Time frame
Day 1 to 24 months post treatment2
Complete Response Rate in second line cohort
The proportion of subjects achieving an objective response of complete response (CR) according to the Lugano Classification, prior to start of another non-study anticancer therapy.
Time frame
Day 1 to 24 months post treatment3
Overall Response Rate
The proportion of subjects achieving an objective response of complete response (CR) or partial response (PR) according to the Lugano Classification, prior to start of another non-study anticancer therapy.
Time frame
Day 1 to 24 months post treatment4
Median Duration of Response
The time from first response to disease progression or death, and will be summarized using Kaplan-Meier estimates.
Time frame
Date of first response to first documented disease progression or date of death from any cause, whichever came first, assessed up to 24 months post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Genmab
Collaborator
Source ClinicalTrials.gov