Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04107727
Status:
UNKNOWN
Last Update Posted:
2022-01-21
First Post:
2019-09-25
Brief Title:
Trial to Compare Efficacy and Safety of ChemotherapyQuizartinib vs ChemotherapyPlacebo in Adults FMS-like Tyrosine Kinase 3 FLT3 Wild-type Acute Myeloid Leukemia AML
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
A 21 Randomized Phase II Trial to Compare the Efficacy and Safety of Standard Chemotherapy Plus Quizartinib Versus Standard Chemotherapy Plus Placebo in Adult Patients With Newly Diagnosed FLT3 Wild-type AML
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Randomized phase II trial to compare the efficacy and safety of standard chemotherapy plus quizartinib versus standard chemotherapy plus placebo in adult patients with newly diagnosed FLT3 wild-type Acute Myeloid Leukemia
Detailed Description:
Multicenter prospective randomized placebo-controlled double-blinded phase II trial to assess the efficacy and safety of an oral quizartinib vs placebo containing front-line chemotherapy-based schedule in FMS-like tyrosine kinase 3 internal tandem duplications FLT3-ITD wild-type Acute Myeloid Leukemia patients
The trial will be conducted in two phases
An open-label safety run-in phase Cytarabine 200 mgm2 days 1-7 Idarubicin 12 mgm2 days 1-3 Quizartinib 60 mgd x 14 days 30mg with strong Cytochrome P450 Family 3 Subfamily A CYP3A inhibitor in a total of 9 patients being observed during 1 cycle of induction to define the final dose for the randomized phase
A randomized double-blinded phase 21 quizartinib at the established dose vs placebo
Experimental Arm Cytarabine 200 mgm2 days 1-7 Idarubicin 12 mgm2 days 1-3 Quizartinib 60 mgd x 14 days 30mg with strong CYP3A inhibitor Standard Arm Cytarabine 200 mgm2 days 1-7 Idarubicin 12 mgm2 days 1-3 Placebo 60 mgd x 14 days 30mg with strong CYP3A inhibitor
272 patients will be included in this phase
The trial will be conducted in two phases
An open-label safety run-in phase Cytarabine 200 mgm2 days 1-7 Idarubicin 12 mgm2 days 1-3 Quizartinib 60 mgd x 14 days 30mg with strong Cytochrome P450 Family 3 Subfamily A CYP3A inhibitor in a total of 9 patients being observed during 1 cycle of induction to define the final dose for the randomized phase
A randomized double-blinded phase 21 quizartinib at the established dose vs placebo
Experimental Arm Cytarabine 200 mgm2 days 1-7 Idarubicin 12 mgm2 days 1-3 Quizartinib 60 mgd x 14 days 30mg with strong CYP3A inhibitor Standard Arm Cytarabine 200 mgm2 days 1-7 Idarubicin 12 mgm2 days 1-3 Placebo 60 mgd x 14 days 30mg with strong CYP3A inhibitor
272 patients will be included in this phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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