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
Joseph Tuscano
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.
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 ritux…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed untreated DEL and DHL diffuse large B-cell lymphoma (DLBCL) meeting the World Health Organization (WHO) criteria for DEL - MYC greater than 40% and BCL2 greater than 50% by immunohistochemistry, or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit and/or triple-hit are included) * Measurable disease by CT or PET/CT scan, with one or more sites of disease \>= 1.5 cm in longest dimension * Age \>= 18 years at time of consent * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karn…
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 CenterSacramento, California
- UC San Diego Moores Cancer CenterSan Diego, California