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Taking people in DenmarkPhase 3

Tests treatment plans for children and teens with acute myeloid leukemia

Compares added and reduced treatments in young patients newly diagnosed with acute myeloid leukemia.

Key facts

Who runs it
Prinses Maxima Centrum voor Kinderoncologie B.V.
Where
Aarhus N, Copenhagen Oe, and Odense C, DenmarkSee the 3 sitesAlso in 11 other countries, 49 sites
Registry title
CHIP-AML22 Master protocol: Protocol for the treatment of children and adolescents with Acute Myeloid Leukemia (AML)
Status
Recruiting
Phase
Phase 3
People taking part
675 people, planned
Started
14 Jul 2023
Expected to end
31 Mar 2036
Type of study
Interventional
Record updated
23 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with newly diagnosed acute myeloid leukemia (AML) that did not come from bone marrow failure or earlier cancer treatment.

Age
From 1 day old up to 18 years old at diagnosis.
Sex
All sexes can join.
Disease stage
Newly diagnosed AML that arose on its own (de novo). For the extra induction part, the leukemia cells must be CD33 positive. For the extra consolidation part, the child must be in the Standard Risk Group.
Earlier treatment
No earlier chemotherapy or radiotherapy.
Biomarker or test result
For the induction randomization, CD33 positivity of the leukemia cells, measured by flow cytometry as a ratio of at least 10.

Main reasons for not taking part

  • AML after bone marrow failure or earlier cancer treatment
  • Myeloid Leukemia of Down syndrome, acute promyelocytic leukemia (APL), MDS or JMML
  • Known active hepatitis B, hepatitis C or HIV infection
  • Known inherited risk of bone marrow failure, such as Fanconi anemia
  • Pregnant or breastfeeding patients

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Newly diagnosed AML. The origin of AML must be de novo (not secondary to bone marrow failure or therapy-related)
  • Age ≥1 day and ≤ 18 years old at initial diagnosis
  • Written informed consent/assent from patients and/or from parents or legal guardians for minor patients, according to local law and regulations
  • Able to comply with scheduled follow-up and with management of toxicity
  • Additional inclusion criteria for the induction randomization: 1) CD33 positivity of leukemic blasts as measured by flow cytometry (mean fluorescence intensity; MFI) at diagnosis (bone marrow aspirate and/or peripheral blood). CD33 positivity is defined as a ratio of at least 10 (using the anti-CD33 clone P67.6) of the geometric MFI of CD33 for the ‘blast population’ divided by the MFI of the CD33 background signal of lymphocytes. 2) Informed consent for participation in randomization Ri
  • Additional inclusion criteria for the consolidation randomization 1) Patients included in the CHIP-AML22 protocol and stratified to Standard Risk Group according to the stratification algorithm of the protocol. 2) Informed consent for participation in randomization Rc

Who cannot take part

  • Previous chemotherapy or radiotherapy. This includes patient with therapy-related AML after previous therapy that is known to increase the risk of secondary AML
  • Additional exclusion criteria for consolidation randomization 1) Patients who previously did not receive chemotherapy according to protocol
  • Known intolerance to any of the chemotherapeutic drugs in the protocol
  • Pregnant or lactating patients, or sexually active female patients of childbearing potential not willing to use a highly effective method of contraception and, if indicated, monthly pregnancy testing for the duration of study therapy and up to 7 months after the completion of all study therapy
  • Sexually active, fertile male patients, not willing to use an effective method of contraception, for the duration of study therapy, and up to 6 months after the completion of all study therapy
  • Concomitant administration of any other experimental drug, or concurrent treatment with any other anti-cancer therapy other than specified in this protocol or in one of the trials linked to this Master protocol, when the study objective is affected
  • Patients with known active hepatitis B, hepatitis C, or HIV infection
  • Patients with a (known) germline predisposition for bone marrow failure, like Fanconi anemia
  • Myeloid Leukemia of Down syndrome (MLDS)
  • Myelodysplastic syndrome (MDS)
  • Evidence of cardiac dysfunction (ejection fraction below 50%, or between 50% and 55% and considered as left ventricular systolic dysfunction by the local (pediatric) cardiologist)
  • Additional exclusion criteria for the induction randomization: 1) Hypersensitivity to the active substance of GO or to any of the excipients listed in section 6.1 of the SPC of GO. 2) Patients with FLT3-ITD/NPM1wt. 3) Elevated bilirubin ≥ grade 3 according to the CTCAE v5.0
  • Patients who in the opinion of the investigator, may not be able to comply with the study requirements of the study
  • Patients for whom informed consent was not obtained
  • Acute promyelocytic leukemia (APL)
  • Juvenile Myelomonocytic Leukemia (JMML)

Where in Denmark

Also in 11 other countries, 49 sites

  • Aarhus UniversitetshospitalAarhus N, DenmarkTaking people
  • RigshospitaletCopenhagen Oe, DenmarkTaking people
  • Odense University HospitalOdense C, DenmarkTaking people

About the trial

What the trial wants to find out

• Overarching objective: To improve the overall EFS for children and adolescents with newly diagnosed AML, compared to NOPHO-DBH AML-2012. • Induction randomization: To assess if adding GO to the first induction course results in better early anti-leukemic efficacy in CD33-positive AML patients, compared to no-GO. • Consolidation randomization: To demonstrate non-inferiority in disease-free survival of two courses of consolidation therapy, by omitting HA3E, as compared to three courses, in the entire standard-risk group eligible for this randomization.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
CHIP-AML22 Master protocol: An open label complex clinical trial in newly diagnosed pediatric de novo AML patients – a study by the NOPHO-DB-SHIP consortium Master Protocol
Plain-language title
Tests treatment plans for children and teens with acute myeloid leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
23 September 2026