About this trial
This phase I trial tests the safety, side effects and best dose of epcoritamab alone and epcoritamab with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R- mini-CHP) for the treatment of diffuse large B cell lymphoma (DLBCL) in elderly or unfit patients. Epcoritamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell receptors, and delivers monomethyl auristatin E to kill them. Rituximab is a monoclonal antibody. It binds to a protein called cluster of differentiation antigen 20 (CD20), which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Epcoritamab alone and epcoritamab with pola-R-mini-CHP may be safe, tolerable and/or effective in treating DLBCL in elderly or unfit patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Previously untreated, histologically confirmed DLBCL according to World Health Organization (WHO) 2016 classification
Documented CD20+ mature B-cell neoplasm according to WHO classification (Swerdlow et al., 2016) or WHO classification (WHO, 2008) based on representative pathology report
Diffuse large B-cell lymphoma note: Other double-/triple-hit lymphomas are not eligible
Untreated patients who transform from low grade marginal zone lymphoma (MZL)
Disqualifiers
Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy
Exception: patients who are treated with prednisone as part of pre-phase treatment
Current grade > 1 peripheral neuropathy by clinical examination
Known or suspected chronic active Epstein-Barr virus infection
Trial design
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood and urine sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Cyclophosphamide
DrugGiven IV
Doxorubicin
DrugGiven IV
Epcoritamab
Biological/VaccineGiven SC
Magnetic Resonance Imaging
Procedure/SurgeryUndergo brain MRI
Polatuzumab Vedotin
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Prednisone
DrugGiven PO
Rituximab
Biological/VaccineGiven IV
Treatment groups
Trial outcomes
Primary outcomes
Progression free survival
Kaplan-Meier estimates will be provided. 95% confidence intervals will be generated.
Secondary outcomes
Overall response rate
Defined as the proportion of patients achieving a complete response (CR) or partial response (PR) based on Lugano criteria. CR defined as the disappearance of all evidence of disease based on Lugano critera. PR defined as a ≥ 50% reduction in tumor burden based on Lugano criteria. Kaplan-Meier estimates will be provided. 95% confidence intervals will be generated.
Duration of response
Kaplan-Meier estimates will be provided. 95% confidence intervals will be generated.
Overall survival
Kaplan-Meier estimates will be provided. 95% confidence intervals will be generated.
Incidence and severity of adverse events
95% confidence intervals will be generated.
Sponsors and contacts
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Jonsson Comprehensive Cancer Center
Lead sponsor
Genmab
Collaborator
This trial is not recruiting at the moment. You can still explore other options: