Actively Recruiting
Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
Led by Taylor Brooks · Updated on 2025-05-11
20
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
T
Taylor Brooks
Lead Sponsor
G
Genmab
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age and older
- Diagnosed with non-Hodgkin lymphoma, including DLBCL (high grade B cell lymphoma, follicular lymphoma grade 3B, and transformed follicular lymphoma) treated with at least 2 lines of systemic anti-cancer therapies including anti-CD20 antibody therapy
- Diagnosed with follicular lymphoma grade 1-3A previously treated with at least 2 lines of systemic anti-cancer therapy including anti-CD20 antibody therapy
- Have at least one risk factor for cytokine release syndrome, such as age 65 or older, elevated lactate dehydrogenase, high white blood cell count before anti-CD20 treatment, advanced lymphoma stage (Ann Arbor Stage III/IV), large tumor size, cardiac comorbidity, bone marrow infiltration, or circulating lymphoma cells in blood
- Adequate bone marrow function with specified minimum hemoglobin, neutrophil, and platelet counts
- ECOG performance status between 0 and 2
- Creatinine clearance of 30 mL/min or higher
- Adequate liver function with AST and/or ALT up to 3 times normal (up to 5 times if liver involved by lymphoma) and total bilirubin up to 1.5 times normal (unless due to Gilbert syndrome or non-hepatic causes)
- Ability and willingness to provide written informed consent
- For women of childbearing potential, agreement to use effective contraception or remain abstinent during treatment
- For men, agreement to use contraception or remain abstinent and refrain from sperm donation during treatment
You will not qualify if you...
- Primary mediastinal B cell lymphoma
- Active central nervous system or meningeal lymphoma involvement
- History of severe allergic or anaphylactic reactions to anti-CD20 antibody therapy
- Active infection requiring systemic treatment within 2 weeks before study drug, including COVID-19
- Active chronic hepatitis B or C or cytomegalovirus infection needing treatment or prevention
- Active cancer other than non-melanoma skin cancer or carcinoma in situ
- HIV positive
- Uncontrolled illnesses such as heart failure, unstable angina, arrhythmia, lung problems, or psychiatric/social issues limiting study compliance
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test
- History of serious and active central nervous system diseases like epilepsy, seizures, paralysis, speech problems, stroke, severe brain injury, dementia, or Parkinson's disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
T
Taylor Brooks, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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