Epcoritamab in Combination With R-CHOP for Patients With Aggressive Non-Hodgkin Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMwanasha Merrill, MD
About this trial
A Phase II, open-label, two-arm, multicenter study evaluating the combination of epcoritamab with R-CHOP chemotherapy in patients with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma.
Eligibility criteria
Qualifiers
Participants must have confirmed CD20-positive aggressive B-cell lymphoma, including de novo or transformed diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; primary mediastinal large B-cell lymphoma (PMBCL); T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus-positive DLBCL, NOS; or follicular lymphoma grade 3b.
Measurable disease per Lugano 2014 criteria.
No prior therapy for DLBCL or FL G3B other than corticosteroids or palliative radiotherapy. Of note, a cycle of anthracycline-containing regimen (given as standard of care prior to study enrollment) is allowed, provided that patients will receive a total of six cycles of chemotherapy as part of their treatment plan. Patients who received one cycle of an anthracycline-containing regimen prior to enrollment will proceed directly to Cycle 2 on study.
Age ≥18 years
Disqualifiers
History of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.
Any prior treatment with a bispecific antibody targeting CD3 and CD20.
Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab.
Requiring immunosuppressive therapy for an ongoing baseline medical condition. For corticosteroids, prednisolone >10 mg daily (or equivalent) qualifies as immunosuppressive and thus be excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma related symptoms, including during screening, and for any adverse events (AE) management during study.
Trial design
Treatments tested in this trial
- Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP)
- Epcoritamab
- Dexamethasone
- Positron Emission Tomography (PET)
- Blood specimen collection
- Questionnaires
- Computerized tomography (CT)
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mwanasha Merrill, MD
Lead sponsor
University of California, San Francisco
Sponsor institution
Source ClinicalTrials.gov