Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04209725
Status:
TERMINATED
Last Update Posted:
2023-12-05
First Post:
2019-12-20
Brief Title:
A Study of CPX-351 Vyxeos With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase II Study Assessing CPX-351 Vyxeos With Quizartinib for the Treatment of Relapsed or Refractory FLT3-ITD Mutation-Positive AML
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a research study to be done at multiple sites in participants with advanced acute myeloid leukemia AML that have a mutation in Fms-like tyrosine kinase-3 internal tandem duplications FLT3-ITD This study is to learn more about an investigational drug quizartinib being tested with the anti-cancer medicine CPX-351 also called Vyxeos which is approved and widely used to treat AML
The purpose of this study is to assess the safety tolerability and survival of patients receiving the combination of CPX-351 and quizartinib
The purpose of this study is to assess the safety tolerability and survival of patients receiving the combination of CPX-351 and quizartinib
Detailed Description:
This is an open-label two-part Phase II clinical trial in patients with relapsed or refractory FLT3-ITD mutation-positive acute myeloid leukemia AML The study is designed to assess the safety and tolerability as well as the efficacy of administering CPX-351 cytarabinedaunorubicin liposome complex with quizartinib CPX-351 is a formulation of two drugs cytarabine and daunorubicin that is administered as the first part of treatment to get rid of as many leukemia cells in your bone marrow as possible Quizartinib is an investigational drug made of a protein that inhibits FLT3 and will be given after CPX-351 has been given The plan for administration is divided into three phases induction consolidation and maintenance
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