Loncastuximab Tesirine and Rituximab for High-Risk Diffuse Large B-cell Lymphoma
This study is testing a treatment for high-risk diffuse large B-cell lymphoma (a type of cancer that starts in white blood cells). It uses two drugs, loncastuximab tesirine and rituximab, followed by a chemotherapy regimen called DA-EPOCH-R (doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone). Loncastuximab tesirine is a targeted therapy that attaches to specific molecules (CD19 receptors) on cancer cells to kill them. Rituximab is another antibody that helps your immune system fight cancer cells by targeting CD20 proteins. The study aims to see how well this treatment works by measuring the complete response rate (how many people's cancer completely disappears) after the first two cycles of treatment. You may be able to join if you have newly diagnosed diffuse large B-cell lymphoma with specific genetic markers (double-expressor lymphoma or double-hit lymphoma) and measurable disease. The study plans to enroll 24 participants, but its current status is unclear.
- Study design
- This is an interventional study, but the phase is not specified. It plans to enroll 24 participants.
- What's involved
- You would receive rituximab, loncastuximab tesirine, etoposide, doxorubicin, vincristine, prednisone, and cyclophosphamide. You would also have blood samples, bone marrow aspiration and biopsy, and CT or PET/CT scans at various times.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have follow-up scans after treatment, but the duration is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05600686
Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of California, DavisInvestigator-initiated
~24 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:CyclophosphamideDoxorubicinEtoposideLoncastuximab TesirinePrednisoneRituximab
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response rate
Measured over First dose through cycle 2 (1 cycle = 3 weeks)
Conditions
Where it's being run
2 sites across 1 statesCalifornia2
Study leadership
- Joseph M Tuscano · PRINCIPAL_INVESTIGATOR · University of California, Davis
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 (Karnofsky \>= 60%)
Life expectancy \>= 6 months
Leukocytes \>= 2,500/uL
Absolute neutrophil count \>= 1,000/uL
Platelets \>= 100,000/uL
Hemoglobin \>= 8 g/dL
Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\< 3 x ULN may be enrolled)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x ULN (AST and/or ALT =\< 5 x ULN for patients with liver involvement)
Alkaline phosphatase =\< 2.5 x ULN (=\< 5 x ULN for patients with documented liver involvement or bone metastases)
Creatinine clearance \>= 30 mL/min by Cockcroft-Gault
Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
Transthoracic echocardiography (TTE) or multigated acquisition scan (MUGA) ejection fraction greater than 40%
Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 7 months after the last dose of study drug
Ability to understand and the willingness to sign a written informed consent document
Human immunodeficiency virus (HIV) infected patients:
No history of acquired immunodeficiency syndrome (AIDS)-defining conditions other than lymphoma or history of CD4+ T-cells below 200/mm\^3 prior to beginning combination anti-retroviral therapy (ART)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
At time of study entry CD4+ T-cells must have recovered from prior lymphoma therapy to \>= 250/mm\^3
At the time of study entry, the HIV viral load must be undetectable by standard laboratory assay
During prior lymphoma therapy, patients must not have experienced documented infections attributed to the HIV positive (+) status
No history of non-adherence to ART and willing to adhere to ART while on study
Antiretroviral drugs with overlapping or similar toxicity profiles as study agents not allowed
Exclusion
Current/ prior use of:
Lymphoma treatment, except for:
1 cycle of DA-EPOCH-R or rituximab, cyclophosphamide, doxorubicin (Adriamycin) vincristine (Oncovin) and prednisolone (R-CHOP)
Radiotherapy \> 2 weeks of initiating study treatment
Nitrosoureas or mitomycin C \> 6 weeks of initiating study treatment
Steroid treatment for DLBCL or steroid monotherapy to stabilize disease while awaiting fluorescence in situ hybridization (FISH)
Other cancer therapies (e.g., prostate, breast hormonal-based therapy) per the principal investigator's discretion
Anthracycline greater than 50 mg/m\^2 (total lifetime) for a prior malignancy
Complementary and alternative medications (CAM) within 1 week prior to initiating study treatment
Treatment with any other investigational agent for any indication within 3 weeks prior to initiating study treatment
Loncastuximab tesirine or rituximab with progression within 6 months of initiating study treatment
Oral or intravenous (IV) antibiotics within 2 weeks prior to initiating study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
Live, attenuated influenza vaccine within 4 weeks prior to initiating study treatment
Immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor, such as anti-tumor necrosis factor \[TNF\] agents) within 14 days prior to initiating study treatment. The following are exceptions to this criterion:
Steroids
Bisphosphonate therapy for symptomatic hypercalcemia or for other reasons (e.g., bone metastasis or osteoporosis)
Known uncontrolled central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement
History of hypersensitivity to anti-CD19 antibodies, loncastuximab tesirine, or any agents used in DA-EPOCH-R
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
History of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in study
Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
Breastfeeding or pregnancy
Clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; or inherited liver disease
Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \[HbsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Documented eczema, psoriasis, or lichen simplex chronicus of vitiligo with dermatologic manifestations (e.g., patients with psoriatic arthritis would be excluded), unless the following apply:
Affected skin covers less than 10% of body surface area (BSA)
Disease is well controlled at baseline and only requires low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
Known active tuberculosis (TB)
Severe infections within 4 weeks prior to initiating study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Major surgical procedure within 28 days prior to initiating study treatment or anticipation of need for a major surgical procedure during the course of the study
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
What this trial measures
- Complete response rateFirst dose through cycle 2 (1 cycle = 3 weeks)
Evaluated per 2014 Lugano criteria. An exact 95% confidence interval will be calculated.