Ignite Creation Date:
2024-05-06 @ 2:23 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02039726
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2014-01-15
Brief Title:
QuANTUM-R An Open-label Study of Quizartinib Monotherapy vs Salvage Chemotherapy in Acute Myeloid Leukemia AML Subjects Who Are FLT3-ITD Positive
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 3 Open-label Randomized Study of Quizartinib AC220 Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication FLT3-ITD Positive Acute Myeloid Leukemia AML Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation HSCT Consolidation
Status:
COMPLETED
Status Verified Date:
2021-02
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 primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival OS compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication FLT3-ITD positive AML who are refractory to or have relapsed within 6 months after first-line AML therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT Number 2013-004890-28 | OTHER | Universal Trial Number UTN U1111-1151-8078 | None |