Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578247
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 3 Double-Blind Randomized Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
QuANTUM-WILD
Brief Summary:
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 FLT3-internal tandem duplication ITD negative acute myeloid leukemia AML
Detailed Description:
This is a clinical trial to compare the effect of quizartinib versus placebo administered with standard induction and consolidation chemotherapy then administered as maintenance therapy for up to 36 cycles on the primary endpoint of overall survival OS in adult patients with newly diagnosed FMS-like tyrosine kinase 3 FLT3-internal tandem duplication ITD negative acute myeloid leukemia AML Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay
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