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
Qualifiers
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
Treatments tested in this trial
- Biospecimen Collection
- Computed Tomography
- Cyclophosphamide
- Doxorubicin
- Epcoritamab
- Magnetic Resonance Imaging
- Polatuzumab Vedotin
- Positron Emission Tomography
- Prednisone
- Rituximab
Treatment groups
Sponsors and collaborators
Jonsson Comprehensive Cancer Center
Lead sponsor
Genmab
Collaborator