Epcoritamab and Pola-R-mini-CHP for the Treatment of Diffuse Large B Cell Lymphoma in Elderly or Unfit Patients (NCT07714421)
A Phase I Study of Single Agent Epcoritamab Followed by Epcoritamab Plus Pola-R-Mini-CHP for Elderly/Unfit Patients With Previously Untreated DLBCL
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (36 items) and avoid the listed exclusions (38 items).
Location: UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
Age range: 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
- Subjects that have transformed from indolent (i) NHL, who have previously been treated with an anthracycline-containing regimen or a CD3-CD20 bispecific antibody
- Patients with known history or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening as confirmed by mandatory magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture
- Aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) \> 3 × upper limit of normal (within 14 days of initiation of study treatment)
- Total bilirubin \> 1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin (within 14 days of initiation of study treatment)
- Patients with a documented history of Gilbert syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible
- International normalization ratio (INR) \> 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation (within 14 days of initiation of study treatment)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diffuse Large B-Cell Lymphoma
- Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma — Tucson, Arizona
- Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients — Daphne, Alabama
- A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) — Tucson, Arizona
- Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas — Birmingham, Alabama
- A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) — Tucson, Arizona
- A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) — Rochester, New York
Explore by condition: All Diffuse Large B-Cell Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.