Actively Recruiting
Epcoritamab Plus Physician's Choice of Platinum-Containing Chemotherapy Before Autologous Hematopoietic Cell Transplant and Consolidation in Relapsed or Refractory Large B-Cell Lymphoma
Led by Joseph Tuscano · Updated on 2025-09-29
25
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
J
Joseph Tuscano
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of epcoritamab with standard platinum-based chemotherapy and autologous hematopoietic cell transplant (autoHCT) in patients with large B-cell lymphoma (LBCL) that has returned after improvement or not responded to previous treatments. This phase II trial focuses on patients with relapsed or refractory LBCL, including several subtypes, aiming to assess the anti-tumor activity and toxicities of this combined approach. Participants receive epcoritamab injected under the skin along with chemotherapy regimens such as RICE, RDHAP/X, or Gemcitabine/Oxaliplatin before undergoing autoHCT. After the transplant, they continue with epcoritamab consolidation therapy across multiple cycles for up to 12 cycles, provided there is no disease progression or unacceptable side effects. Chemotherapy cycles repeat every 21 or 28 days depending on the regimen used. Throughout the study, patients undergo various tests including heart scans (echocardiography or MUGA), CT or PET/CT scans, and blood tests to monitor disease status and treatment effects. Some may also have brain imaging before starting. After completing treatment, participants are followed up at 30 days and then every 4 months for up to 2 years to observe outcomes such as complete response rates and survival measures.
CONDITIONS
Brief Title
Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically or cytologically confirmed relapsed or refractory large B-cell lymphoma (LBCL), including various subtypes
- Relapsed or refractory disease following standard frontline chemotherapy as defined by PET/CT per the Lugano criteria
- Received one or more prior systemic therapies for large cell lymphoma (radiation or corticosteroids alone not counted)
- Candidate for platinum-containing chemotherapy and autologous hematopoietic cell transplantation per institutional guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky score �360%)
- Measurable disease with at least one lymph node > 1.5 cm or one extranodal lesion > 1 cm
- Aged 18 years or older at consent
- Creatinine clearance �345 mL/min
- Liver enzymes (ALT and AST) �3 3 times upper limit of normal
- Bilirubin �3 1.5 times upper limit of normal unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia
- Hemoglobin �3 8.0 g/dL (transfusion allowed if due to marrow involvement)
- Absolute neutrophil count �3 1000/uL (growth factor support allowed if due to marrow involvement)
- Platelet count �3 75,000/uL or �3 50,000/uL if marrow involvement or splenomegaly (transfusion allowed)
- Coagulation tests (PT/INR/aPTT) �3 1.5 times upper limit of normal
- HIV patients on stable antiviral therapy with controlled viral load and CD4 count for 1 year
- Patients with controlled hepatitis B or cured hepatitis C infections
- Women of child-bearing potential and men must agree to use contraception during and for 12 months after treatment
- Signed informed consent form
You will not qualify if you...
- Any unresolved adverse events from prior lymphoma therapy above grade 1 except hair loss and minor lab abnormalities
- Uncontrolled illnesses, including infections
- Active central nervous system or meningeal lymphoma involvement (unless CNS complete response is confirmed)
- Receiving other investigational treatments
- Previous treatment with bispecific T-cell engagers
- Recent investigational drug use within 4 weeks or 5 half-lives before study
- Concurrent anti-cancer treatments except some hormone therapies
- Motor or sensory neuropathy grade 2 or higher
- History of other cancers unless treated and disease-free for 3 years
- Active infections or autoimmune diseases requiring permanent immunosuppression (low-dose steroids allowed)
- Pregnant or breastfeeding women
- Prior allogeneic stem cell or organ transplant
- Significant cardiac disease or recent heart attack, stroke, or abnormal ECG
- Recent live vaccines within 28 days before treatment
- Immune encephalopathy score less than 10
- Allergy or intolerance to epcoritamab or related drugs
- Active hepatitis B or C infection
- Known HIV infection
- Active cytomegalovirus infection
- Plans for pregnancy or sperm donation during and for 12 months after treatment
- Active or recent infections requiring systemic treatment
- Active COVID-19 infection or recent exposure without confirmed negative tests
- Suspected active or untreated latent tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 cycles (each 28 days) plus autoHCT week 0
Participants receive epcoritamab subcutaneously on days 1, 8, 15, and 22 of each cycle along with platinum-containing chemotherapy every 2 or 3 weeks per standard of care for up to 3 cycles, followed by autologous hematopoietic cell transplant (autoHCT) on week 0.
Weekly visits during epcoritamab dosing and chemotherapy cycles; 1 visit for autoHCT
Duration - Up to 12 cycles of 28 days each without disease progression or unacceptable toxicity
After autoHCT, participants continue epcoritamab subcutaneously on a decreasing schedule over up to 12 cycles to consolidate treatment.
Multiple visits: weekly during cycles 1-3, twice monthly during cycles 4-9, and monthly thereafter
Duration - Up to 2 years post autoHCT
Participants are followed up after completing study treatment to monitor their health and any long-term effects.
1 visit at 30 days post-treatment, then visits every 4 months
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
S
Selina Laqui
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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