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New treatment option for Large B-cell Lymphoma
Official title A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
ClinicalTrials.gov ID: NCT05464719
What this study is testing
What is Loncastuximab Tesirine?
Loncastuximab Tesirine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for large b-cell lymphoma.
Also referred to as Lonca.
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
- To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.
- 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
- Eligible people will be considered for inclusion in this study if they meet the following criteria:
- Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade...
- Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial
- ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
You likely can't join if
- people will be ineligible for this study if they meet the following criteria:
- Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or...
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. prostate, cervix, bladder, breast) unless disease free for at...
- History of Richter's transformation of chronic lymphocytic leukemia (CLL)
- Treatment with CAR T-cell therapy on clinical trial as immediate treatment before enrollment
- Prior treatment with lonca
See the full eligibility criteria
- Eligible people will be considered for inclusion in this study if they meet the following criteria:
- Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade B-cell lymphoma
- Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial
- ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Achievement of PR according to Lugano 2014 response criteria 30 days after CAR T-cell therapy
- At least 30 days must have elapsed since CAR T-cell therapy infusion
- No evidence of CD19 expression after CAR T-cell therapy infusion is required for enrolment
- No additional anti-tumoral therapy, with the exclusion of palliative radiotherapy, must have been received after CAR T-cell therapy
- Absolute neutrophil count (ANC) of ≥ 1.0×109/L without growth factor support for 3 days prior to screening assessment.
- Platelet count of ≥ 50×109/L without transfusion for 3 days prior to screening assessment.
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min
- Serum alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 2.5 upper limit of normal (ULN)
- Total bilirubin ≤2 mg/dL, except in people with Gilbert's syndrome.
- Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion
- Baseline oxygen saturation \> 92% on room air
- No evidence or suspicion of lymphoma actively involving the central nervous system (CNS)
- Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of...
- Resolution of any previous CRS and/or ICANS to grade 0. 4.3
- people will be ineligible for this study if they meet the following criteria:
- 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)
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. prostate, cervix, bladder, breast) unless disease free for at least 12 months
- History of Richter's transformation of chronic lymphocytic leukemia (CLL)
- Treatment with CAR T-cell therapy on clinical trial as immediate treatment before enrollment
- Prior treatment with lonca
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active...
- Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of HIV, hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative...
- people with active cardiac atrial or cardiac ventricular lymphoma involvement
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrolment
- Primary immunodeficiency
- History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring active systemic immunosuppression/systemic disease modifying agents within the last 2 years
- History of clinically significant deep vein thrombosis or pulmonary embolism within 1 month of enrollment per investigators discretion.
- Any medical condition likely to interfere with assessment of safety or how well it works of study treatment
- History of severe immediate hypersensitivity reaction to any of the agents used in this study
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the PBD on the fetus or infant.
- people of both genders who are not willing to practice birth control. Women of childbearing potential must use a highly effective method of contraception (hormonal birth control such as birth control pills, intravaginal...
- In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation Trial Treatments
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 - 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?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.