Ignite Creation Date:
2024-05-06 @ 12:27 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03766516
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2018-11-14
Brief Title:
Registry of BrentuximabVedotinin Patients With RR Anaplastic Large Cell Lymphoma or Classical HL
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
A Multi-center and Non-interventional Registry of BrentuximabVedotinin Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma or Classical Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2022-02
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:
BRAVO
Brief Summary:
In case of relapsed or refractory ALK-negative ALCL patients high-dosage chemotherapy stem cell transplantation is a universal salvage option for patients with sensitivity to anti-cancer treatment and a relatively successful salvage rate can be expected
Recently there has been a report of successful stem cell transplantation with full response to BrentuximabVedotin induced before stem cell transplantation and BrentuximabVedotins role as a bridge therapy before stem cell transplantation has also been suggested
Hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical characteristics Based on the 2008 WHO classification Hodgkin lymphoma has two types-nodular lymphocyte predominant type and classical type-and the classical type is further classified into four types nodular sclerosis mixed cellularity lymphocyte depletion and lymphocyte-rich type
Recently immune checkpoint inhibitor is reported as a very effective treatment for relapsed Hodgkin lymphoma and more active treatment such as stem cell transplantation is considered for younger patients
Treatment with Brentuximabvedotin targeting CD30 is also very effective for the treatment of relapsed Hodgkin lymphoma and considered a good option for patients who are not suitable for stem cell transplantation or aged patients
It shows consistent response to anti-CD30 antibody treatment in relation to relapsed anaplastic large cell lymphoma or Hodgkin lymphoma The effect of Brentuximabvedotin BV has been proven for relapsed or intractable ALCL targeting CD30 as an antibody-chemical adhesive in the recent phase-2 study
As Korea currently lacks real-world evidence in relation to BV this study was conducted to address BVs effect as salvage therapy for patients with relapsedrefractoryanaplastic large cell lymphoma or Hodgkin lymphoma This study identified the clinical results for treatment patterns and patients using the collected data and derived critical evidence for treatment decisions
Recently there has been a report of successful stem cell transplantation with full response to BrentuximabVedotin induced before stem cell transplantation and BrentuximabVedotins role as a bridge therapy before stem cell transplantation has also been suggested
Hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical characteristics Based on the 2008 WHO classification Hodgkin lymphoma has two types-nodular lymphocyte predominant type and classical type-and the classical type is further classified into four types nodular sclerosis mixed cellularity lymphocyte depletion and lymphocyte-rich type
Recently immune checkpoint inhibitor is reported as a very effective treatment for relapsed Hodgkin lymphoma and more active treatment such as stem cell transplantation is considered for younger patients
Treatment with Brentuximabvedotin targeting CD30 is also very effective for the treatment of relapsed Hodgkin lymphoma and considered a good option for patients who are not suitable for stem cell transplantation or aged patients
It shows consistent response to anti-CD30 antibody treatment in relation to relapsed anaplastic large cell lymphoma or Hodgkin lymphoma The effect of Brentuximabvedotin BV has been proven for relapsed or intractable ALCL targeting CD30 as an antibody-chemical adhesive in the recent phase-2 study
As Korea currently lacks real-world evidence in relation to BV this study was conducted to address BVs effect as salvage therapy for patients with relapsedrefractoryanaplastic large cell lymphoma or Hodgkin lymphoma This study identified the clinical results for treatment patterns and patients using the collected data and derived critical evidence for treatment decisions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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