Actively Recruiting
An Open Label Complex Clinical Trial in Newly Diagnosed Pediatric de Novo AML Patients - a Study by the NOPHO-DB-SHIP Consortium, Master Protocol
Led by Princess Maxima Center for Pediatric Oncology · Updated on 2025-08-05
905
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
Sponsors
P
Princess Maxima Center for Pediatric Oncology
Lead Sponsor
E
European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new treatment approaches for children and adolescents newly diagnosed with de novo acute myeloid leukemia (AML) to improve their chances of event-free survival. The study aims to increase cure rates while minimizing unnecessary toxicity by comparing different chemotherapy regimens and adding targeted therapies. This phase 3 master protocol trial also explores risk-adapted treatment based on genetic markers and disease response, as well as cardioprotective measures and quality of life during and after treatment. Participants receive chemotherapy courses with different consolidation strategies, with some patients randomized to receive either three or two consolidation chemotherapy cycles. Additionally, for CD33-positive patients, the study compares adding gemtuzumab ozogamicin to the first induction chemotherapy course versus not adding it. Patients with certain genetic profiles may receive the FLT3 inhibitor quizartinib alongside chemotherapy and as continuation therapy after stem cell transplant if disease markers remain. The study involves stratification of patients into risk groups to tailor treatment intensity and includes use of a heart-protecting drug during specific chemotherapy courses. During the trial, participants will undergo diagnostic tests including flow cytometry and genetic analysis to guide treatment allocation. Researchers will monitor event-free survival over five years and assess treatment toxicity, safety, healthcare resource use, and quality of life through questionnaires. Frequent follow-up visits will evaluate disease status and side effects. The trial plans long-term observation to understand effectiveness and safety of the strategies tested, and participation requires compliance with follow-up and management of side effects throughout treatment and beyond.
CONDITIONS
Brief Title
CHIP-AML22/Master: An Open Label Complex Clinical Trial in Newly Diagnosed Pediatric de Novo AML Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed acute myeloid leukemia (AML) of de novo origin
- Age between 1 day and 18 years at initial diagnosis
- Written informed consent/assent from patient and/or parent/legal guardian
- Ability to comply with scheduled follow-up and toxicity management
- CD33 positivity for randomization Ri (if applicable)
- Stratified to Standard Risk Group for randomization Rc (if applicable)
- Informed consent for participation in respective randomizations (Ri or Rc)
You will not qualify if you...
- Previous chemotherapy or radiotherapy, including therapy-related AML
- Known germline predisposition for bone marrow failure (e.g., Fanconi anemia)
- Myeloid leukemia of Down syndrome
- Acute promyelocytic leukemia (APL)
- Myelodysplastic syndrome (MDS)
- Juvenile Myelomonocytic Leukemia (JMML)
- Known intolerance to chemotherapy drugs in the protocol
- Cardiac dysfunction with shortening fraction below 28%
- Pregnant or lactating females not using effective contraception
- Sexually active fertile males not using effective contraception
- Concurrent use of other experimental drugs or anti-cancer therapies not specified in protocol
- Inability to comply with study requirements
- Known active hepatitis B, hepatitis C, or HIV infection
- Lack of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Several months of chemotherapy courses
Participants receive chemotherapy courses including induction and consolidation phases, with randomization to different treatment regimens based on risk groups and CD33 positivity.
Multiple visits during induction and consolidation courses
Duration - Up to 5 years
Participants are monitored for event-free survival and long-term safety outcomes after completion of treatment.
Scheduled follow-up visits over 5 years
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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