Actively Recruiting
CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients
Led by Princess Maxima Center for Pediatric Oncology · Updated on 2025-08-05
60
Participants Needed
1
Research Sites
434 weeks
Total Duration
On this page
Sponsors
P
Princess Maxima Center for Pediatric Oncology
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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-AML22/Quizartinib) 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.
CONDITIONS
Official Title
CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be enrolled in the CHIP-AML22/Master study before joining this trial
- Presence of FLT3-ITD positive and NPM1 wild-type confirmed by local labs
- Patients aged from 1 month to 18 years at diagnosis
- Karnofsky performance status above 50% for those over 16 years; Lansky performance status above 50% for those 16 years or younger
- Adequate kidney function with estimated GFR of at least 50 mL/min/1.73 m2
- Adequate liver function with bilirubin less than 1.5 times the upper normal limit (or up to 5 times if related to leukemia) and AST/ALT less than 5 times normal (or up to 10 times if related to leukemia)
- Life expectancy greater than 6 weeks
- Negative pregnancy test within 2 weeks before enrollment for girls at or after menarche
- Ability to swallow quizartinib or receive it by feeding tube
- Written informed consent from patients or guardians according to local laws
You will not qualify if you...
- Patients with only extramedullary disease
- Uncontrolled or significant heart diseases including long QT syndrome, serious arrhythmias, left ventricular dysfunction (EF below 55%), recent heart attack or uncontrolled angina, heart block, slow heart rate below 50 bpm, uncontrolled high blood pressure, complete left bundle branch block, or severe heart failure
- Known HIV infection or active liver disease such as hepatitis B or C
- Gastrointestinal diseases that affect drug absorption
- Use of strong or moderate CYP3A inducers during the study; strong CYP3A4 inhibitors allowed only with quizartinib dose adjustment except during safety run-in
- Known allergy to study drugs or their ingredients
- Other serious illnesses that prevent completing treatment as planned
- Participation in other interventional studies that interfere with this trial's outcomes
- Additional exclusions during safety run-in: presence of CNS3 disease or current use of strong CYP3A4 inhibitors unless they can be stopped without washout period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Princess Máxima Center for pediatric oncology
Utrecht, Utrecht, Netherlands, 3584 CS
Actively Recruiting
Research Team
R
Renske Benedictus
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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