Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563596
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Epcoritamab Zanubrutinib and Rituximab EZR for RR FL Relapsed or Refractory Follicular Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of Epcoritamab Zanubrutinib and Rituximab EZR for Treatment of Relapsed or Refractory Follicular Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 determine how effective and safe the combination of epcoritamab zanubrutinib and rituximab is in treating participants with relapse or refractory Follicular Lymphoma FL
The names of the study drugs involved in this research study are
Epcoritamab a type of antibody
Zanubrutinib a type of Bruton tyrosine kinase inhibitor
Rituximab a type of monoclonal antibody
The names of the study drugs involved in this research study are
Epcoritamab a type of antibody
Zanubrutinib a type of Bruton tyrosine kinase inhibitor
Rituximab a type of monoclonal antibody
Detailed Description:
This is an open-label multicenter phase II study to evaluate the efficacy and safety of epcoritamab zanubrutinib and rituximab EZR for participants with relapsed or refractory follicular lymphoma FL The trial will commence with a six participant lead-in cohort
The US Food and Drug Administration FDA has approved epcoritamab for people who have received at least 2 prior treatments for follicular lymphoma
The US FDA has approved zanubrutinib in combination with a drug called obinutuzumab for people who have received at least 2 prior treatments for follicular lymphoma
The FDA has also approved rituximab as a treatment option for follicular lymphoma
The research study procedures include screening for eligibility in-clinic visits urine tests blood tests stool samples saliva samples electrocardiograms ECGs bone marrow biopsies Computerized Tomography CT scans Positron Emission Tomography PET scans and questionnaires
Participants will receive study treatment for approximately 24 months and will be followed every 6 months thereafter for up to 10 years
It is expected that about 24 people will take part in this research study
Genmab is supporting this research study by providing the study drug epcoritamab and funding for the study BeiGene is supporting this research study by providing the study drug zanubrutinib and funding for the study
The US Food and Drug Administration FDA has approved epcoritamab for people who have received at least 2 prior treatments for follicular lymphoma
The US FDA has approved zanubrutinib in combination with a drug called obinutuzumab for people who have received at least 2 prior treatments for follicular lymphoma
The FDA has also approved rituximab as a treatment option for follicular lymphoma
The research study procedures include screening for eligibility in-clinic visits urine tests blood tests stool samples saliva samples electrocardiograms ECGs bone marrow biopsies Computerized Tomography CT scans Positron Emission Tomography PET scans and questionnaires
Participants will receive study treatment for approximately 24 months and will be followed every 6 months thereafter for up to 10 years
It is expected that about 24 people will take part in this research study
Genmab is supporting this research study by providing the study drug epcoritamab and funding for the study BeiGene is supporting this research study by providing the study drug zanubrutinib and funding for the study
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