Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475235
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-20
Brief Title:
Pembrolizumab Chemotherapy in Newly Diagnosed PCNSL
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Pilot Study of Pembrolizumab in Combination with Chemotherapy in Newly Diagnosed Primary Central Nervous System Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This research study is studying if the investigational drug Pembrolizumab in combination with chemotherapy helps primary central nervous system lymphoma with acceptable side effects
This research study involves a combination of the below drugs
Pembrolizumab a type of monoclonal antibody
Methotrexate a type of anti-metabolite
Temozolomide a type of alkylating agent
Rituximab a type of antibody
This research study involves a combination of the below drugs
Pembrolizumab a type of monoclonal antibody
Methotrexate a type of anti-metabolite
Temozolomide a type of alkylating agent
Rituximab a type of antibody
Detailed Description:
This is an open label pilot trial of Pembrolizumab in combination with chemotherapy in participants with newly diagnosed Primary Central Nervous System Lymphoma PCNSL
The US Food and Drug Administration FDA has not approved Pembrolizumab for Primary Central Nervous System Lymphoma PCNSL but it has been approved for other uses
The FDA has approved Rituximab for PCNSL
The FDA has not approved Temozolomide for PCNSL but it has been approved for other uses
The FDA has not approved Methotrexate for PCNSL but it has been approved for other uses
The research study procedures include screening for eligibility blood and urine tests Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans testicular ultrasounds electrocardiograms ECG and eye exams
It is expected that about 15 people will take part in this research study
Merck Co is supporting this research study by providing the study drug pembrolizumab
The US Food and Drug Administration FDA has not approved Pembrolizumab for Primary Central Nervous System Lymphoma PCNSL but it has been approved for other uses
The FDA has approved Rituximab for PCNSL
The FDA has not approved Temozolomide for PCNSL but it has been approved for other uses
The FDA has not approved Methotrexate for PCNSL but it has been approved for other uses
The research study procedures include screening for eligibility blood and urine tests Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans testicular ultrasounds electrocardiograms ECG and eye exams
It is expected that about 15 people will take part in this research study
Merck Co is supporting this research study by providing the study drug pembrolizumab
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None