Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 10:39 AM
Study NCT ID:
NCT05006534
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2021-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polatuzumab Vedotin in Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
The Efficacy and Adverse Effect of Polatuzumab Vedotin in Patients With Diffuse Large B Cell Lymphoma: an Observation Study
Status:
COMPLETED
Status Verified Date:
2021-08
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 study enrolled patients with relapsed or refractory diffuse large B cell lymphoma treated with polatuzumab vedotin-based chemoimmunotherapies. Patients were allowed to use chemotherapy regimens other than Rituximab and Bendamustine and transplantation following polatuzumab vedotin was also allowed.
Detailed Description:
Polatuzumab vedotin has been demonstrated to be an effective treatment for patients with relapsed/refractory diffuse large B cell lymphoma in an international phase II clinical trial. The clinical trials was conducted in Europe and the United States. Although there is a phase III trial about polatuzumab vedotin in newly diagnosed patients with diffuse large B cell lymphoma, the double-blind design has limited the efficacy assessment and side effect observation, making it difficult to provide clinicians with further information.
This program hopes to evaluate the clinical course and treatment response of these patients in order to facilitate clinicians' understanding of this drug and to improve patients' quality of life and medical care, as well as to prevent the occurrence of related complications and treatment toxicity.
This program hopes to evaluate the clinical course and treatment response of these patients in order to facilitate clinicians' understanding of this drug and to improve patients' quality of life and medical care, as well as to prevent the occurrence of related complications and treatment toxicity.
Study Oversight
Has Oversight DMC:
False
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?: