Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510361
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy
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:
This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment
The name of the study drug in this research study is
-Epcoritamab a type of antibody
The name of the study drug in this research study is
-Epcoritamab a type of antibody
Detailed Description:
This is a prospective phase 2 single arm open label trial investigating epcoritamab in participants with follicular lymphoma FL who have failed to achieve a complete response after frontline therapy Epcoritamab is a bispecific antibody a synthetic protein that activates the immune system to target cancer cells
The US Food and Drug Administration FDA has not approved epcoritamab for follicular lymphoma but it has been approved for other uses
The research study procedures include screening for eligibility treatment study visits questionnaires Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans electrocardiograms blood tests and bone marrow biopsies
Participants will receive treatment for up to 12 cycles and will be followed for 2 years
It is expected that about 35 people will take part in this research study
Genmab Inc is funding this research study by providing the study drug Epcoritamab
The US Food and Drug Administration FDA has not approved epcoritamab for follicular lymphoma but it has been approved for other uses
The research study procedures include screening for eligibility treatment study visits questionnaires Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans electrocardiograms blood tests and bone marrow biopsies
Participants will receive treatment for up to 12 cycles and will be followed for 2 years
It is expected that about 35 people will take part in this research study
Genmab Inc is funding this research study by providing the study drug Epcoritamab
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