Large B-cell Lymphoma study: Epcoritamab vs Loncastuximab Tesirine
Official title Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT06919939
What this study is testing
What is Epcoritamab?
This is an investigational injectable medicine being studied as a potential treatment for large B-cell lymphoma. It is designed to bind to specific proteins on the surface of cancer cells to help the immune system recognize and attack them.
Also referred to as Epkinly.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if using two specific cancer drugs together is safe and helps reduce or eliminate lymphoma cells.
- Who it's for
- The study is looking for adults with large B-cell lymphoma that has come back or has not responded to previous treatments.
- What's involved
- Participants will receive two different cancer drugs, Epcoritamab and Loncastuximab Tesirine, likely through IV infusions, along with regular medical checks.
- Time commitment
- The duration and specific visit schedule are not detailed in the provided text.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women aged 18 years or older at the time of signing informed consent.
- Able and willing to sign the informed consent form (ICF).
- Ability to comply with the trial protocol.
- LBCL or DLBCL, not otherwise specified (NOS)
- High-grade B-cell lymphoma (NOS or double/triple hit [technically classified in WHO 2016 as high-grade B-cell lymphoma (HGBCL), with Myc and B-cell...
You likely can't join if
- Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging...
- Prior treatment with anti-cluster of differentiation 19 (anti-CD19) chimeric antigen receptor T-cell (CAR-T) therapy
- Prior exposure to bispecific T-cell engaging antiCD20XCD3 antibodies
- Prior autologous or allogenic stem cell transplant
- Pulmonary fibrosis affecting patient's exercise tolerance.
- Chronic obstructive pulmonary disease (COPD) affecting patient's exercise tolerance.
See the full eligibility criteria
Who can join
- Men and women aged 18 years or older at the time of signing informed consent.
- Able and willing to sign the informed consent form (ICF).
- Ability to comply with the trial protocol.
- LBCL or DLBCL, not otherwise specified (NOS)
- High-grade B-cell lymphoma (NOS or double/triple hit [technically classified in WHO 2016 as high-grade B-cell lymphoma (HGBCL), with Myc and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) translocations])
- Transformed from follicular lymphoma, marginal zone lymphoma (MZL), and nodular lymphocyte predominant Hodgkin lymphoma
- Follicular lymphoma stage 3B
- Primary mediastinal B-cell lymphoma previously treated with checkpoint inhibitor Note: Relapsed disease is defined as disease that has recurred ≥6 months after completion of therapy.
- Participants who have received at least one prior systemic therapy for LBCL including anti-cluster of differentiation 20 (anti-CD20) monoclonal antibody and anthracycline-containing therapy.
- Measurable disease by 2014 Lugano Classification. (Participants who have measurable disease, defined as at least 1 bi-dimensionally measurable nodal lesion, defined as \>1.5 cm in its longest dimension, or at least 1...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
- Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9 cells/L
- Hemoglobin ≥8.0 g/dL without blood transfusion in the past week
- Platelet count ≥75 × 10\^9 platelets/L or ≥ 50 × 10\^9 platelets/L if bone marrow involvement or splenomegaly
- Total bilirubin ≤1.5 × upper limit normal (ULN). Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible (≤3x...
- Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤3.0 × ULN or ≤5 × ULN in the presence of liver involvement by lymphoma.
- i. Creatinine within normal institutional limits, or calculated creatinine clearance ≥40 mL/min by the Cockcroft-Gault Equation or other institutional standard methods
- Willingness to avoid pregnancy during the trial and for at least 12 months after the last dose of the trial intervention.
- Patients with history of human immunodeficiency virus (HIV) are eligible, provided they are stable on anti-retroviral therapy, have cluster of differentiation 4 (CD4) count ≥200/µL, and have an undetectable viral load.
- Life expectancy of at least 12 weeks
- For patients receiving glucocorticoid treatment at screening: treatment must be tapered down and administered with a maximum of 25 mg daily in the last 14 days before the first dose of epcoritamab.
What rules you out
- Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by...
- Prior treatment with anti-cluster of differentiation 19 (anti-CD19) chimeric antigen receptor T-cell (CAR-T) therapy
- Prior exposure to bispecific T-cell engaging antiCD20XCD3 antibodies
- Prior autologous or allogenic stem cell transplant
- Pulmonary fibrosis affecting patient's exercise tolerance.
- Chronic obstructive pulmonary disease (COPD) affecting patient's exercise tolerance.
- Onset of unstable angina pectoris within 6 months of signing ICF
- Acute myocardial infarction within 6 months of signing ICF
- Congestive heart failure (grade III or IV as classified by the New York Heart Association
- Pregnant or breast feeding
- Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
- Chronic or current active infectious disease (including severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2) requiring systemic antibiotics, antifungal, or antiviral treatment or any major episode of infection...
- Exposure to a live vaccine within 30 days of administration or anticipation that a live attenuated vaccine will be required during the study.
- Inactivated influenza vaccinations may be given during the influenza season.
- An approved coronavirus disease 2019 (COVID-19) vaccine (messenger ribonucleic acid (mRNA), inactivated virus, and replication deficient viral vector vaccines) is allowed.
- Active hepatitis B infection a. Patients who are hepatitis B surface antigen (HbsAg) negative and hepatitis B core antibody (HbcAb) positive must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR)...
- Active hepatitis C infection a. Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation
- At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms.
- Patients with severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment.
- Patients with seizure disorder requiring therapy with a last convulsion within two years from enrollment.
- Patients with impaired decision-making capacity.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.