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

Part of paid clinical trials in Sacramento, California.

Sponsor
Joseph Tuscano
Study ID
NCT05600686
Phase
PHASE2
Status
Recruiting
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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

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Loncastuximab Tesirine — BIOLOGICAL
    Given IV
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
May 24, 2023
Status verified
Nov 2025
Primary completion
Feb 1, 2026
Completion
Feb 1, 2028

Study Design

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

Arms

  • Experimental: Treatment (Lonca-R, DA-EPOCH-R)
    Patients receive rituximab IV, loncastuximab tesirine IV, etoposide IV, doxorubicin IV, vincristine IV, prednisone PO, and cyclophosphamide IV on study. Patients also undergo collection of blood samples and bone marrow aspiration and biopsy at screening and CT or PET/CT at screening, throughout the study, and during follow up.

Primary Outcome Measure

Complete response rate [ Time Frame: First dose through cycle 2 (1 cycle = 3 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Selina Laqui
[email protected]
916-734-0565
Joseph M. Tuscano (PRINCIPAL_INVESTIGATOR)
UC San Diego Moores Cancer CenterSan DiegoCalifornia92037
Erin Reid, MD
[email protected]
Erin Reid, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CAUC San Diego Moores Cancer Center· San Diego, CA

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