RecruitingPhase 2NCT05600686

Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma

A Phase 2 Study of Loncastuximab Tesirine and Rituximab (Lonca-R) Followed by DA-EPOCH-R in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma


Sponsor

Joseph Tuscano

Enrollment

24 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two medications — loncastuximab tesirine and rituximab — followed by a standard chemotherapy regimen for newly diagnosed high-risk diffuse large B-cell lymphoma (DLBCL), an aggressive type of blood cancer. These are cases where the cancer cells have certain genetic changes (MYC and BCL2/BCL6 gene rearrangements) that make standard treatment less effective. **You may be eligible if...** - You have newly diagnosed DLBCL with specific high-risk genetic features (double-hit or triple-hit lymphoma, or double-expressor lymphoma) - You have not yet received any treatment for this lymphoma - You have at least one measurable tumor site - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have already received treatment for this lymphoma - You have certain serious health conditions including active hepatitis B, HIV, or serious heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Given IV

DRUGDoxorubicin

Given IV

DRUGEtoposide

Given IV

BIOLOGICALLoncastuximab Tesirine

Given IV

DRUGPrednisone

Given PO

BIOLOGICALRituximab

Given IV

DRUGVincristine

Given IV


Locations(2)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UC San Diego Moores Cancer Center

San Diego, California, United States

View Full Details on ClinicalTrials.gov

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NCT05600686


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