Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04676360
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2020-12-15
Brief Title:
Belantamab Mafodotin In Plasmablastic Lymphoma ALK Large B-Cell Lymphoma
Sponsor:
Jacob Soumerai MD
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Multicenter Phase 2 Study of Belantamab Mafodotin in Relapsed or Refractory Plasmablastic Lymphoma and ALK Large B-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-05
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:
In this research study is looking to see how safe and effective belantamab mafodotin is in relapsed or refractory plasmablastic lymphoma or ALK large B-cell lymphoma
This research study involves the study drug belantamab mafodotin
Belantamab mafodotin is an antibody-drug conjugate ADC which is the combination of an antibody a protein that binds to cells and a drug It works by using the antibody portion to enter into the lymphoma cells and then releasing the drug portion to kill the lymphoma cells
This research study involves the study drug belantamab mafodotin
Belantamab mafodotin is an antibody-drug conjugate ADC which is the combination of an antibody a protein that binds to cells and a drug It works by using the antibody portion to enter into the lymphoma cells and then releasing the drug portion to kill the lymphoma cells
Detailed Description:
This is a multicenter phase 2 study of belantamab mafodotin on participants with plasmablastic lymphoma and ALK large B-cell lymphomaThe research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
This research study involves the study drug belantamab mafodotin
Participants may receive the study treatment until progression or intolerance and will be followed up to 2 years
It is expected that about 25 people will take part in this research study
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved belantamab mafodotin as a treatment for any disease This study drug is investigational and it is not known whether participants will benefit from taking belantamab mafodotin
This research study involves the study drug belantamab mafodotin
Participants may receive the study treatment until progression or intolerance and will be followed up to 2 years
It is expected that about 25 people will take part in this research study
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved belantamab mafodotin as a treatment for any disease This study drug is investigational and it is not known whether participants will benefit from taking belantamab mafodotin
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