Actively Recruiting
Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-05-06
40
Participants Needed
1
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.
CONDITIONS
Official Title
Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological diagnosis of diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, or T cell/histiocyte-rich large B-cell lymphoma
- No prior systemic treatment for current lymphoma
- Ineligible for anthracycline chemotherapy due to age 80 or older, frailty, or heart failure
- Ejection fraction between 30% and less than 50%
- Asymptomatic or minimally symptomatic heart failure (NYHA class 1 or 2)
- Stage II bulky (>7 cm), III, or IV disease
- ECOG performance status 2 or better (or 3 improving to 2 before enrollment)
- Measurable disease with at least one nodal lesion ≥1.5 cm or extra-nodal lesion >1 cm
- Adequate organ and marrow function including neutrophil count ≥1.0 x 10^9/L, platelet count ≥75 x 10^9/L, liver and kidney function within specified limits
- Agree to avoid blood donation during treatment and for 12 months after
- Able to give informed consent
- Females must agree to avoid breastfeeding and follow pregnancy prevention guidelines
- Males must agree to use birth control and avoid sperm donation during and after treatment
You will not qualify if you...
- Known central nervous system lymphoma or leptomeningeal disease
- Prior malignancy within 3 years except certain treated skin cancers or cervical carcinoma in situ
- Life-threatening illness or organ dysfunction that could risk safety
- Uncontrolled HIV, active hepatitis B or C, or significant infection
- History of severe allergic reaction to anti-CD20 antibodies or bispecific antibodies
- Immunodeficiency or recent systemic immunosuppressant therapy (with exceptions)
- Significant cardiovascular disease including recent heart attacks or severe heart failure
- Significant ECG abnormalities
- Recent stroke, seizure disorders, or intracranial hemorrhage
- More than mild pericardial effusion
- Pregnant or breastfeeding
- Recent participation in other investigational studies or recent surgery
- Chronic corticosteroid use above specified doses for other diseases
- Life expectancy less than 6 months
- Neuropathy greater than Grade 1
- Prior exposure to epcoritamab
- Active autoimmune disease requiring treatment in past 2 years
- History or current pneumonitis requiring steroids or active pneumonitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Dai Chihara, 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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