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
Qualifiers
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
Treatments tested in this trial
- Epcoritamab
- Rituximab combined with cyclophosphamide, vincristine, and prednisone
- Rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone
- Rituximab combined with polatuzumab, cyclophosphamide, doxorubicin, and prednisone
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Genmab
Collaborator
Source ClinicalTrials.gov