Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTaylor Brooks
About this trial
The goal of this clinical trial is to is to determine the safety, feasibility and efficacy of siltuximab prophylaxis of cytokine release syndrome and neurotoxicity occurring after epcoritamab subcutaneous administration for participants with large b-cell lymphoma (DLBCL) or follicular lymphoma (FL).
Participants will receive siltuximab, prior to the injection of epcoritamab. Epcoritamab is administered in 28 day cycles for one year. After this injection, the physician will continue to watch participants for side effects and follow the condition for a minimum of 60 days.
Eligibility criteria
Qualifiers
Adults 18 years of age and older
Diagnosis of non-Hodgkin lymphoma.
DLBCL (including high grade B cell lymphoma and follicular lymphoma grade 3B and transformed follicular lymphoma) treated with at least 2 lines of systemic antineoplastic therapies, including at least 1 anti-CD20 monoclonal antibody - containing therapy
FL grade 1-3A previously treated with at least 2 lines of systemic antineoplastic therapy, including at least 1 anti-CD20 monoclonal antibody - containing therapy.
Disqualifiers
Primary mediastinal B cell lymphoma
Active central nervous system or meningeal involvement by lymphoma
History of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy
Active bacterial, viral, fungal, mycobacterial, parasitic or other infection requiring systemic therapy within 2 weeks prior to first dose of study drug. This includes participants with COVID-19 infection
Trial design
Treatments tested in this trial
- Siltuximab
- Epcoritamab
- Gemcitabine and oxaliplatin
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Taylor Brooks
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Genmab
Collaborator
AbbVie
Collaborator
RECORDATI GROUP
Collaborator
Source ClinicalTrials.gov