Epcoritamab and Pola-R-mini-CHP for the Treatment of Diffuse Large B Cell Lymphoma in Elderly or Unfit Patients

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT07714421
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Diffuse Large B-Cell Lymphoma
  • Grade 3b Follicular Lymphoma
  • High Grade B-Cell Lymphoma
  • Primary Mediastinal Large B-Cell Lymphoma
  • Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin — DRUG
    Given IV
  • Epcoritamab — BIOLOGICAL
    Given SC
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo brain MRI
  • Polatuzumab Vedotin — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Dec 8, 2026
Status verified
Jul 2026
Primary completion
Oct 8, 2030
Completion
Oct 8, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (epcoritamab, pola-r-mini-CHP)
    See Detailed Description

Primary Outcome Measure

Progression free survival [ Time Frame: From initiation of treatment to disease progression based on the investigator-based assessments per Lugano criteria or death due to any causes, up to 6 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Sven De Vos (PRINCIPAL_INVESTIGATOR)

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