NCT06262438RecruitingPhase 2
CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 26 Jan 2024
- Start date
- 6 Feb 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- Princess Maxima Center for Pediatric Oncology
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT06262438
- EU CT number
- 2023-505000-27-01
- EudraCT number
- 2022-002886-14
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 6 Feb 2024 to the primary completion date, Jun 2028
- 50 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Enrollment on CHIP-AML22/Master:
- Patients must be enrolled on the CHIP-AML22/Master prior to enrollment on CHIP-AML/Quizartinib linked-trial, and may have received a diagnostic work-up according to the master protocol. Induction treatment can be started as standard of care.
- FLT3-ITD+ and wild-type NPM1:
- Presence of FLT3-ITD+ and NPM1 wild type in bone marrow or peripheral blood provided by the local laboratories, as part of standard of care diagnostics. The results of FLT3-ITD testing must be obtained prior to the first dose of quizartinib (e.g., Induction course 1, Day 10).
- Age:
- Patients must be from 1 month to ≤ 18 years old at initial diagnosis
- Performance status Karnofsky performance status score of \>50% for subjects \>16 years of age, and a Lansky performance status score of \>50% for subjects ≤16 years of age.
- Organ function criteria:
- These criteria must be met based on the results before start of any chemotherapy (e.g., MEC) a. Adequate Renal Function Defined as:
- Calculated eGFR ≥ 50 mL/min/1.73 m2 using the Schwartz formula. b. Adequate Liver Function Defined as:
- Total or direct (conjugated) bilirubin \< 1.5xULN for age (≤ 5xULN if related to leukemic involvement), AND
- Aspartate transaminase (AST) and alanine transaminase (ALT) \<5xULN (\<10×ULN if related to leukemic involvement)
- Life expectancy: \> 6 weeks
- Pregnancy test:
- Serum/urine pregnancy test (for all girls ≥ age of menarche) negative within 2 weeks prior to enrollment on the quizartinib linked-trial.
- Taking quizartinib:
- Patients must be able to reliably swallow or administer quizartinib by NG tube.
- Informed consent:
- Written informed consent/assent for the quizartinib linked trial from patients and/or from parents or legal guardians for minor patients, according to local law and regulations.
- General exclusion criteria:
- Patients with only extramedullary disease
- Uncontrolled or significant cardiovascular disease, including -Diagnosed or suspected congenital long QT syndrome
- -History of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes); any history of arrhythmia will be discussed with sponsor, the national coordinator and C.I.the prior to subject's entry into the study.
- -QT interval corrected \>450 ms: QTc interval corrected with Fridericia's formula (QTcF) for subjects ≥ 6 years of age at the time of enrollment.
- -Left ventricular systolic dysfunction (LVSD), defined as ejection fraction (EF) below 55% during the screening for the CHIP-AML22/Master protocol.
- -History of uncontrolled angina pectoris or myocardial infarction within 6 months.
- -History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have nohistory of fainting or clinically relevant arrhythmias while using the pacemaker).
- -Heart rate \<50 beats/minute on ECG during the screening for the CHIP-AML22/Master protocol (In case,adolescents with a normal sinusoidal rhythm and no evidence of other cardiac dysfunction will be discussed with sponsor, the national coordinator and C.I. the prior to subject's entry into the study.)
- -Uncontrolled hypertension (e.g., systolic blood pressure and /or diastolic blood pressure that is, on repeated measurement, at or above the 95th percentile for sex, age, and height).
- History of complete left bundle branch block.
- History of New York Heart Association Class 3 or 4 heart failure.
- Known history of HIV or active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C)
- Underlying GI disease that may affect absorption of study drug
- Use of strong or moderate CYP3A inducers will be prohibited throughout the duration of the study. Strong CYP3A4 inhibitors will be allowed with a concomitant dose reduction of quizartinib with the exception during the safety run-in.
- History of hypersensitivity to any of the study medications or their excipients.
- Other serious illnesses or medical conditions, that will likely make it impossible to complete treatment according to protocol (e.g., patients who should not be given any of the study medications based on the SmPC)
- Currently participating in other investigational interventional procedures, if it interferes with any endpoints of the quizartinib trial.
- 2\) Additional exclusion criteria during safety run-in:
- Patients with CNS3 disease
- Using strong CYP3A4 inhibitors (If patient can stop using strong CYP3A4 inhibitors, he/she will be allowed to enroll. In such case, no washout is required for the strong CYP3A4 inhibitor)
Age in the registry: 1 month to 18 years · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Tallinn Children´s Hospital Coordinator of this site? Confirm its status | Tallinn | Estonia | Recruiting |
| Tartu University Hospital Coordinator of this site? Confirm its status | Tartu Linn | Estonia | Recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Pohjois-Savon hyvinvointialue Coordinator of this site? Confirm its status | Kuopio | Finland | Recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Recruiting |
| Pirkanmaan hyvinvointialue Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| Landspitali Coordinator of this site? Confirm its status | Reykjavik | Iceland | Completed |
| Vilniaus universiteto ligonine Santaros klinikos VšĮ Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
| Bernu Kliniska Universitates Slimnica VSIA Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Prinses Maxima Centrum voor Kinderoncologie B.V. Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsoe | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Region Oestergoetland Coordinator of this site? Confirm its status | Linkoping | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.