Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476665
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
BESPONSA INJECTION 1MG SPECIAL INVESTIGATION PEDIATRIC INVESTIGATION
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 of BESPONSA for pediatric patients
BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients A type of leukemia blood cancer that comes on quickly and is fast growing In acute lymphocytic leukemia there are too many lymphoblasts early-stage white blood cells in the blood and bone marrow Also called ALL
The registration criteria for this study are
Never used BESPONSA before
18 years at the start of treatment with BESPONSA
All patients in this study will receive BESPONSA according to the prescriptions
Patients will be followed up as follow
Treatment phase From the day of treatment initiation Day 1 to Day 28 post-treatment to collect information on safety eg adverse events
Follow-up phase From Day 29 post-treatment to Week 52 to collect information on VODSOS
BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients A type of leukemia blood cancer that comes on quickly and is fast growing In acute lymphocytic leukemia there are too many lymphoblasts early-stage white blood cells in the blood and bone marrow Also called ALL
The registration criteria for this study are
Never used BESPONSA before
18 years at the start of treatment with BESPONSA
All patients in this study will receive BESPONSA according to the prescriptions
Patients will be followed up as follow
Treatment phase From the day of treatment initiation Day 1 to Day 28 post-treatment to collect information on safety eg adverse events
Follow-up phase From Day 29 post-treatment to Week 52 to collect information on VODSOS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: