Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262438
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-01-26
Brief Title:
CHIP-AML22Quizartinib Quizartinib Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD and NPM1wt AML Patients
Sponsor:
Princess Maxima Center for Pediatric Oncology
Organization:
Princess Maxima Center for Pediatric Oncology
Study Overview
Official Title:
A Phase II Single Arm Open Label Study on the Safety Efficacy Pharmacokinetics Pharmacodynamics of Quizartinib Chemotherapy and as Single-agent After High Dose Therapy in Newly Diagnosed Pediatric FLT3-ITD and NPM1wt AML Patients
Status:
RECRUITING
Status Verified Date:
2024-02
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:
CHIP-AML22Q
Brief Summary:
The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients while avoiding unnecessary toxicity The linked Quizartinib trial CHIP-AML22Quizartinib is a phase II single arm open label study on the safety efficacy pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type
Detailed Description:
The CHIP-AML22Quizartinib study is a single-arm multinational multicenter open-label phase II study with a safety run-in aiming to assess the safety efficacy pharmacokinetics and pharmacodynamics of quizartinib a FLT3-inhibitor as IMP added to standard of care chemotherapy in newly diagnosed FLT3-ITD positive and NPM1 wild-type AML pediatric patients
This study is a linked trial to the CHIP-AML22Master protocol Patients will start in the CHIP-AML22Master study and if they are FLT3-ITD positive and NPM1 wild-type can be enrolled in the CHIP-AML22Quizartinib study
This study is a linked trial to the CHIP-AML22Master protocol Patients will start in the CHIP-AML22Master study and if they are FLT3-ITD positive and NPM1 wild-type can be enrolled in the CHIP-AML22Quizartinib study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002886-14 | EUDRACT_NUMBER | None | None |
| 2023-505000-27 | OTHER | EU CT Number | None |