Actively Recruiting
CHIP-AML22/Master: An Open Label Complex Clinical Trial in Newly Diagnosed Pediatric de Novo AML Patients
Led by Princess Maxima Center for Pediatric Oncology · Updated on 2025-08-05
905
Participants Needed
1
Research Sites
646 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
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.
CONDITIONS
Official 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 from birth (day 0) up to 18 years old at initial diagnosis
- Written informed consent or assent from patient and/or parent/legal guardian according to local regulations
- Ability to comply with scheduled follow-up and management of treatment toxicity
- For randomization Ri: CD33 positivity of leukemic blasts at diagnosis and consent for Ri randomization
- For randomization Rc: Stratified to Standard Risk Group and consent for Rc randomization
You will not qualify if you...
- Previous chemotherapy or radiotherapy, including therapy-related AML
- Known germline predisposition for bone marrow failure, such as Fanconi anemia
- Myeloid leukemia associated with Down syndrome (ML-DS)
- Diagnosis of acute promyelocytic leukemia (APL)
- Diagnosis of myelodysplastic syndrome (MDS)
- Diagnosis of juvenile myelomonocytic leukemia (JMML)
- Known intolerance to any chemotherapy drugs in the protocol
- Evidence of cardiac dysfunction (shortening fraction below 28%)
- Pregnant or lactating female patients, or sexually active females unwilling to use effective contraception during study and up to 7 months after
- Sexually active fertile males unwilling to use effective contraception during study and up to 6 months after
- Concurrent treatment with other experimental drugs or anti-cancer therapies outside this protocol
- Investigator's opinion that patient cannot comply with study requirements
- Known active hepatitis B, hepatitis C, or HIV infection
- Lack of informed consent obtained
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
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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