Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma
NCT05600686 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-11-25
Summary
This phase II trial evaluates whether loncastuximab tesirine and rituximab followed by dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone works to treat patients with high risk diffuse large B-cell lymphoma. Loncastuximab tesirine is a monoclonal antibody called loncastuximab, linked to a drug called tesirine. It is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them. Rituximab is a monoclonal antibody. It binds to a protein called 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. Chemotherapy drugs such as doxorubicin, vincristine, and cyclophosphamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. 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. Giving loncastuximab tesirine and rituximab in combination with dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone may be more effective at treating high risk diffuse large B-cell lymphoma patients than standard treatments.
Conditions
- Double-Expressor Lymphoma
- High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
- High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
Interventions
- DRUG
-
Given IV
- DRUG
-
Doxorubicin
Given IV
- DRUG
-
Etoposide
Given IV
- BIOLOGICAL
-
Loncastuximab Tesirine
Given IV
- DRUG
-
Given PO
- BIOLOGICAL
-
Given IV
- DRUG
-
Vincristine
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
ADC Therapeutics S.A.
collaborator INDUSTRY -
Joseph Tuscano
lead OTHER
Principal Investigators
-
Joseph M Tuscano · University of California, Davis
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-24
- Primary Completion
- 2026-02-01
- Completion
- 2028-02-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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