Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-14 @ 3:48 PM
Study NCT ID:
NCT05923112
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BESPONSA Injection 1 mg Special Investigation
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
BESPONSA® INJECTION 1 MG SPECIAL INVESTIGATION
Status:
COMPLETED
Status Verified Date:
2025-10
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:
The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia.
Registration criteria for this study is all patients who starting BESPONSA in Japan from its launch to the market to April 30, 2020.
All patients in this study will receive BESPONSA according to the prescriptions.
Patients will be followed up as follow.
* 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA.
* Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.
Registration criteria for this study is all patients who starting BESPONSA in Japan from its launch to the market to April 30, 2020.
All patients in this study will receive BESPONSA according to the prescriptions.
Patients will be followed up as follow.
* 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA.
* Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCT05923112 | REGISTRY | ClinicalTrials.gov | View |