Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510309
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating participants with untreated Marginal Zone Lymphoma MZL
The names of the study drugs involved in this study are
Venetoclax a type of inhibitor
Rituximab a type of antibody
The names of the study drugs involved in this study are
Venetoclax a type of inhibitor
Rituximab a type of antibody
Detailed Description:
This is a phase II study of rituximab plus venetoclax in participants with MZL who have not had prior chemotherapy The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating Marginal Zone Lymphoma
The US Food and Drug Administration FDA has not approved venetoclax for MZL but it has been approved for other uses
The FDA has approved rituximab as a treatment option for MZL
The research study procedures include screening for eligibility study treatment visits Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans blood tests bone marrow and tumor biopsies and electrocardiograms
Participants will receive study treatment for up to 24 months and will be followed for 1 year after discontinuation of the study drugs
It is expected that about 33 people will take part in this research study
Abbvie Inc is funding this research study by providing venetoclax
The US Food and Drug Administration FDA has not approved venetoclax for MZL but it has been approved for other uses
The FDA has approved rituximab as a treatment option for MZL
The research study procedures include screening for eligibility study treatment visits Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans blood tests bone marrow and tumor biopsies and electrocardiograms
Participants will receive study treatment for up to 24 months and will be followed for 1 year after discontinuation of the study drugs
It is expected that about 33 people will take part in this research study
Abbvie Inc is funding this research study by providing venetoclax
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None