NCT05600686

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Joseph Tuscano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To obtain a preliminary estimate of the anti-tumor activity of loncastuximab tesirine and rituximab (lonca-R) in newly diagnosed double-expressor lymphoma (DEL) and double-hit lymphoma (DHL). SECONDARY OBJECTIVES: I. To obtain additional efficacy measures of lonca-R in newly diagnosed DEL and DHL. II. To assess safety and tolerability of lonca-R followed by dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone (DA-EPOCH-R) as coded by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. OUTLINE: Patients receive rituximab intravenously (IV), loncastuximab tesirine IV, etoposide IV, doxorubicin IV, vincristine IV, prednisone orally (PO), and cyclophosphamide IV on study. Patients also undergo collection of blood samples and bone marrow aspiration and biopsy at screening and computed tomography (CT) or positron emission tomography (PET)/CT at screening, throughout the study, and during follow up.

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

Type	Name	Description
DRUG	Cyclophosphamide	Given IV
DRUG	Doxorubicin	Given IV
DRUG	Etoposide	Given IV
BIOLOGICAL	Loncastuximab Tesirine	Given IV
DRUG	Prednisone	Given PO
BIOLOGICAL	Rituximab	Given IV
DRUG	Vincristine	Given IV

Timeline

• Start date: 2023-05-24
• Primary completion: 2026-02-01
• Completion: 2028-02-01
• First posted: 2022-10-31
• Last updated: 2025-11-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study