Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-02 @ 1:53 AM
Study NCT ID:
NCT05053659
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma
Sponsor:
Paolo Caimi, MD
Organization:
Study Overview
Official Title:
Phase I Trial of Loncastuximab Tesirine and Venetoclax for Treatment of Relapsed/ Refractory Non-Hodgkin Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
This is a phase I trial designed to evaluate the safety and tolerability of loncastuximab tesirine given in combination with venetoclax for treatment of relapsed/refractory non - Hodgkin lymphoma.
Loncastuximab tesirine is an investigational (experimental) drug that works by targeting a protein in cancer cells (called CD19) and delivering a small amount of chemotherapy directly to the cancer cells. Loncastuximab tesirine is experimental because it is not approved by the Food and Drug Administration (FDA). Venetoclax, is a targeted anti-cancer drug, which works by imitating a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the loncastuximab tesirine regimen is believed to increase the chance of getting relapsed or refractory B cell lymphoma cancer in remission. Venetoclax is approved by the FDA for treatment in some types of cancer, but is not approved by the FDA for the treatment of lymphoma soit is considered experimental in this study. Up to 36 subjects will take in this phase I research study.
The primary objective for this study: To determine the safety and tolerability of the combination of loncastuximab tesirine and venetoclax to identify the recommended phase 2 dose (RP2D) of these agents.
Secondary objectives are:
* To describe the adverse event profile of the combination of loncastuximab tesirine and venetoclax.
* To describe the overall response rate (ORR) and complete response rate (CRR) of relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
* To describe the overall survival (OS) and progression free survival (PFS) of subjects with relapsed / refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
* To describe the disease-free survival, the disease specific survival and time to treatment failure of subjects with relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
Loncastuximab tesirine is an investigational (experimental) drug that works by targeting a protein in cancer cells (called CD19) and delivering a small amount of chemotherapy directly to the cancer cells. Loncastuximab tesirine is experimental because it is not approved by the Food and Drug Administration (FDA). Venetoclax, is a targeted anti-cancer drug, which works by imitating a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the loncastuximab tesirine regimen is believed to increase the chance of getting relapsed or refractory B cell lymphoma cancer in remission. Venetoclax is approved by the FDA for treatment in some types of cancer, but is not approved by the FDA for the treatment of lymphoma soit is considered experimental in this study. Up to 36 subjects will take in this phase I research study.
The primary objective for this study: To determine the safety and tolerability of the combination of loncastuximab tesirine and venetoclax to identify the recommended phase 2 dose (RP2D) of these agents.
Secondary objectives are:
* To describe the adverse event profile of the combination of loncastuximab tesirine and venetoclax.
* To describe the overall response rate (ORR) and complete response rate (CRR) of relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
* To describe the overall survival (OS) and progression free survival (PFS) of subjects with relapsed / refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
* To describe the disease-free survival, the disease specific survival and time to treatment failure of subjects with relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: