Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT04624893
Status:
UNKNOWN
Last Update Posted:
2020-11-12
First Post:
2020-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin
Sponsor:
Jiangsu Cancer Institute & Hospital
Organization:
Study Overview
Official Title:
A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin in the Treatment of Patients With Transplantation Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
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:
To assess the clinical outcomes following treatment with Pola in combination with Bendamustine, Rituximab (BR) or Rituximab (R) in patients with R/R DLBCL who are not eligible for transplantation in the real-world setting.
Detailed Description:
This study is a multi-center retrospective observational study. It aims to evaluate the effectiveness and safety of polatuzumab vedotin treatment in patients with hematopoietic stem cell transplantation ineligible relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), who met the criteria to access Pola through the compassionate use program (CUP). Based on the medical records of patients in the four participating hospitals, the study database will be established by using the unified case report form (CRF) to search extract information the data of target population from the hospital database, that is, the variables without personal identification information.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: