Loncastuximab Tesirine + Venetoclax for Non-Hodgkin's Lymphoma
Trial Summary
Do I need to stop taking my current medications for the trial?
The trial requires you to stop taking strong CYP3A inhibitors or inducers at least 14 days or 5 half-lives before starting the study drugs. If you're on these medications, you'll need to discontinue them before participating.
What data supports the effectiveness of the drug Venetoclax for treating Non-Hodgkin's Lymphoma?
Is the combination of Loncastuximab Tesirine and Venetoclax safe for humans?
Loncastuximab Tesirine has shown a tolerable safety profile in clinical trials for non-Hodgkin's lymphoma, with side effects like low white blood cell counts, low platelet counts, and elevated liver enzymes. Venetoclax is generally safe for chronic lymphocytic leukemia, with manageable side effects such as low white blood cell counts. Both drugs have been approved for use in specific conditions, indicating they are considered safe for humans in those contexts.12678
What makes the drug combination of Loncastuximab Tesirine and Venetoclax unique for treating Non-Hodgkin's Lymphoma?
This drug combination is unique because Loncastuximab Tesirine is an antibody-drug conjugate that targets CD19 on B cells, delivering a cytotoxic agent directly to cancer cells, while Venetoclax is a BCL-2 inhibitor that helps restore the natural process of cell death in cancer cells. Together, they offer a novel approach by combining targeted delivery with apoptosis restoration, which may enhance treatment effectiveness for Non-Hodgkin's Lymphoma.24567
What is the purpose of this trial?
The purpose of this study is to determine the correct dose and safety of combining two new cancer drugs, loncastuximab tesirine and venetoclax, as a treatment for relapsed or refractory B cell lymphoma.These drugs are used to treat some lymphomas, but have not yet been tested in combination for the treatment of lymphoma. The main goal of this study is to determine the safety of the combination.
Research Team
Paolo Caimi, MD
Principal Investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with Non-Hodgkin Lymphoma who've had at least two prior treatments and still have measurable disease. They must be in a stable condition, not pregnant or breastfeeding, willing to use effective contraception, and without serious unresolved treatment side effects from previous therapies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive loncastuximab tesirine intravenously on day 1 and venetoclax orally on days 1-5 of each 21-day cycle, with premedication and hydration
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Loncastuximab Tesirine
- Venetoclax
Loncastuximab Tesirine is already approved in United States, European Union for the following indications:
- Diffuse large B-cell lymphoma (DLBCL)
- DLBCL arising from low-grade lymphoma
- High-grade B-cell lymphoma
- Diffuse large B-cell lymphoma (DLBCL)
- DLBCL arising from low-grade lymphoma
- High-grade B-cell lymphoma
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Who Is Running the Clinical Trial?
Paolo Caimi, MD
Lead Sponsor
Brian Hill, MD, PhD
Lead Sponsor
Brian Hill
Lead Sponsor