Ignite Creation Date:
2024-05-06 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03575325
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2018-06-21
Brief Title:
VyxeosCPX-351 in Adults w RR Acute Lymphoblastic Leukemia
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Single-Arm Open-Label Phase 2 Pilot Study of Vyxeos CPX-351 in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study involves Vyxeos CPX-351 a formulation of a fixed combination of the two anti-tumor drugs cytarabine and daunorubicin that will be given as an infusion over 90 minutes This study will use what is called a liposome injection This is a special fat capsule called a liposome that surrounds the cytarabine and daunorubicin and protects the drugs from being eliminateddestroyed by the body
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None