Actively Recruiting
Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
Led by Academic and Community Cancer Research United · Updated on 2024-09-26
120
Participants Needed
6
Research Sites
360 weeks
Total Duration
On this page
Sponsors
A
Academic and Community Cancer Research United
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.
CONDITIONS
Official Title
Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Confirmed diagnosis of diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, or transformed indolent B-cell lymphoma with CD20 positive tumor cells within 6 months before registration
- Treated with CD19-directed CAR-T therapy and have partial response at day 30 PET-CT assessment
- Measurable disease present
- Eastern Cooperative Oncology Group performance status 0, 1, or 2
- Absolute neutrophil count of at least 1,000/mm^3
- Platelet count of at least 50,000/mm^3
- Hemoglobin 7.0 g/dL or higher if asymptomatic, or above 8.0 g/dL if symptomatic
- Total bilirubin at or below 1.5 times upper limit of normal unless due to Gilbert's syndrome or liver involvement, with total bilirubin up to 5 times upper limit allowed
- Alanine aminotransferase and aspartate transaminase at or below 3 times upper limit of normal (5 times if liver involved)
- Creatinine clearance of at least 45 mL/min
- Negative pregnancy test for women of childbearing potential
- Able to provide informed consent within 28 days prior to registration
- Willing to return to study site for follow-up and provide mandatory tissue and blood samples
You will not qualify if you...
- Bulky disease with any tumor 7.5 cm or larger at day 30 PET-CT assessment
- Progressive disease, stable disease, or complete response at day 30 PET-CT assessment
- Pregnant or nursing persons, or unwilling to use adequate contraception if of childbearing potential
- Prior treatment with CD20xCD3 bispecific antibody
- Use of CD20-targeted monoclonal antibody within 4 weeks prior to registration
- Ongoing cytokine release syndrome or neurotoxicity after CAR-T therapy
- History of grade 4 cytokine release syndrome or neurotoxicity post CAR-T
- Primary CNS lymphoma or CNS involvement by lymphoma
- Significant systemic illness or other severe diseases interfering with safety assessment
- Uncontrolled infections requiring systemic treatment within 14 days prior to registration
- Symptomatic congestive heart failure (NYHA class 3 or 4), unstable angina, or unstable cardiac arrhythmia within 14 days
- Psychiatric illness or social situations limiting study compliance
- History or presence of CNS disorders such as seizures, cerebrovascular events, cerebellar disease, or autoimmune CNS diseases
- Receiving other investigational agents for primary cancer within 14 days
- Other active malignancies requiring therapy within 2 years (except localized non-melanoma skin cancer)
- Clinically significant cardiovascular disease including recent myocardial infarction, unstable cardiac conditions, arrhythmias grade 2 or higher, or significant ECG abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
2
Siteman Cancer Center at Washington University
St Louis, Missouri, United States, 63110
Not Yet Recruiting
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
5
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
6
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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