Actively Recruiting
Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma
Led by Joseph Tuscano · Updated on 2025-11-25
24
Participants Needed
2
Research Sites
244 weeks
Total Duration
On this page
Sponsors
J
Joseph Tuscano
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed untreated double-expressor lymphoma (DEL) or double-hit lymphoma (DHL) diffuse large B-cell lymphoma meeting WHO criteria
- Measurable disease with at least one site \u2265 1.5 cm by CT or PET/CT scan
- Age 18 years or older at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (Karnofsky \u2265 60%)
- Life expectancy of at least 6 months
- Leukocytes count \u2265 2,500/uL
- Absolute neutrophil count \u2265 1,000/uL
- Platelet count \u2265 100,000/uL
- Hemoglobin level \u2265 8 g/dL
- Total bilirubin \u2264 1.5 times the institutional upper limit of normal (ULN), or \u2264 3 x ULN for patients with Gilbert disease
- AST and/or ALT \u2264 3 times ULN (\u2264 5 times ULN for patients with liver involvement)
- Alkaline phosphatase \u2264 2.5 times ULN (\u2264 5 times ULN for liver involvement or bone metastases)
- Creatinine clearance \u2265 30 mL/min by Cockcroft-Gault
- Activated partial thromboplastin time (aPTT) \u2264 1.5 times ULN unless on stable therapeutic anticoagulation
- Heart ejection fraction greater than 40% by echocardiography or MUGA scan
- Women of child-bearing potential must use effective contraception from consent until 10 months after last dose
- Men with female partners of child-bearing potential must use effective contraception from consent until 7 months after last dose
- Ability to understand and sign informed consent
- HIV-infected patients eligible if on effective antiretroviral therapy with undetectable viral load and CD4+ T-cells \u2265 250/mm3
- No history of AIDS-defining conditions other than lymphoma or CD4+ T-cells below 200/mm3 before ART
- No documented infections related to HIV during prior lymphoma therapy
- No history of non-adherence to ART and willing to adhere during study
- No antiretroviral drugs with overlapping toxicity with study agents
You will not qualify if you...
- Prior lymphoma treatment except one cycle of DA-EPOCH-R or R-CHOP, or limited radiotherapy or certain cancer therapies as allowed
- Anthracycline exposure greater than 50 mg/m2 lifetime
- Use of complementary and alternative medications within 1 week prior to study
- Use of investigational agents within 3 weeks prior to study
- Prior loncastuximab tesirine or rituximab with progression within 6 months
- Use of oral or IV antibiotics within 2 weeks prior to study, except prophylactic antibiotics
- Live attenuated influenza vaccine within 4 weeks prior to study
- Use of immunosuppressive medications within 14 days before study, except steroids or bisphosphonates
- Uncontrolled central nervous system lymphoma involvement
- History of severe allergic or hypersensitivity reactions to study drugs or related antibodies
- Clinically significant fluid accumulation requiring drainage
- Pregnancy or breastfeeding
- Significant liver disease including active hepatitis, cirrhosis, fatty liver, or inherited liver disease, except past/resolved hepatitis B or controlled hepatitis C
- Skin conditions like eczema or psoriasis covering \u2265 10% body surface area or not well controlled
- Active tuberculosis
- Severe infections within 4 weeks prior to study
- Major surgery within 28 days prior to study or planned during study
- Uncontrolled illnesses including active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
2
UC San Diego Moores Cancer Center
San Diego, California, United States, 92037
Actively Recruiting
Research Team
J
Joseph M Tuscano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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