CHIP-AML22/Master: An Open Label Complex Clinical Trial in Newly Diagnosed Pediatric de Novo AML Patients

NCT05994690 | Recruiting Phase 3 DMC

• 1 other identifier: 2023-504999-25-00
• Study Type: interventional
• Target: 905
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Myeloid Leukemia in Children

Outcome Measures

Primary Outcomes (3)

• Overarching primary objective

  Event Free Survival (EFS)

  5 years

• Primary objective Randomisation Consolidation

  Disease Free Survival (DFS)

  5 years

• Primary objective Randomisation Induction

  MRD \<0.1% leukemic cells in the BM

  5 years

Secondary Outcomes (14)

• Overarching secondary objective - efficacy 1

  8 months

• Overarching secondary objective - efficacy 2

  3 months

• Overarching secondary objective - efficacy 3

  8 months

• Overarching secondary objective - efficacy 4

  8 months

• Overarching secondary objective - efficacy 5

  5 years

Study Arms (4)

Standard arm Rc

ACTIVE COMPARATOR

3 consolidation courses (HAM + HA3E + FLA)

Drug: Standard Intervention Rc

Investigational arm Rc

EXPERIMENTAL

2 consolidation courses (HAM + FLA)

Drug: Investigational Intervention Rc

Standard arm Ri

ACTIVE COMPARATOR

No addition om gemtuzumab ozogamicin (GO) to the first induction course of CD33-positive AML

Drug: Standard Intervention Ri

Investigational arm Ri

EXPERIMENTAL

Addition om gemtuzumab ozogamicin (GO) to the first induction course of CD33-positive AML

Drug: Investigational Intervention Ri

Interventions

Standard Intervention Rc DRUG

3 consolidation courses (HAM + HA3E + FLA)

Standard arm Rc

Investigational Intervention Rc DRUG

2 consolidation courses (HAM + FLA)

Investigational arm Rc

Standard Intervention Ri DRUG

No addition of GO to first induction course

Standard arm Ri

Investigational Intervention Ri DRUG

Addition of GO to first induction course

Investigational arm Ri

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients are eligible for the study if they fulfil all four criteria below:
• Newly diagnosed AML as defined by the diagnostic criteria in section 8.1. Note that different blast thresholds may apply for different genetic abnormalities in case of low blast percentages. The origin of AML must be de novo (not secondary to bone marrow failure or therapy-related).
• Age ≥ 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. Informed consent should ideally be obtained before day 7 of induction course 1, as patients that are eligible for the linked quizartinib trial should be enrolled before the end of induction course 1, and in view of the planned Mylotarg® randomisation. Thus, standard of care diagnostics and induction treatment may be started before informed consent has been obtained.
• Able to comply with scheduled follow-up and with management of toxicity.
• CD33 positivity of leukemic blasts as measured by flow cytometry at diagnosis (bone marrow aspirate and/or peripheral blood).
• Informed consent for participation in randomization Ri
• Patients included in the CHIP-AML22 protocol and stratified to Standard Risk Group according to the stratification algorithm of the protocol
• Informed consent for participation in randomization Rc

You may not qualify if:

• Patients are excluded if any of the criteria below are present:
• Previous chemotherapy or radiotherapy. This includes patients with therapy-related AML after previous cancer therapy. These patients may be treated according to the master protocol but will not be part of the formal study population, and data of these patients will not be collected.
• Patients with a (known) germline predisposition for bone marrow failure, like Fanconi anemia.
• Myeloid Leukemia of Down syndrome (ML-DS). Patients with ML-DS are recommended to be treated according to the international ML-DS protocol. Patients with AML and DS older than 5 years who often lack GATA1 mutation and do not have typical myeloid leukemia of DS may be treated according to the master protocol but will not be part of the formal study population, hence data of these patients will not be collected.
• Acute promyelocytic leukemia (APL).
• Myelodysplastic syndrome (MDS).
• Juvenile Myelomonocytic Leukemia (JMML).
• Known intolerance to any of the chemotherapeutic drugs in the protocol.
• Evidence of cardiac dysfunction (shortening fraction below 28%).
• Pregnant or lactating patients, or sexually active female patients of childbearing potential not willing to use an highly effective method of contraception 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 under investigation, 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, is not allowed.
• Patients who in the opinion of the investigator, may not be able to comply with the study requirements of the study.
• Patients with known active hepatitis B, hepatitis C, or HIV infection.
• Patients for whom informed consent was not obtained.

Sponsors & Collaborators

• Princess Maxima Center for Pediatric Oncology: lead
• European Commission: collaborator

Study Sites (1)

Princess Máxima Center for pediatric oncology

Utrecht, Utrecht, 3584 CS, Netherlands

RECRUITING

Study Officials

• Gertjan Kaspers, Prof. Dr.

  Pediatric Oncologist

  STUDY CHAIR

• Michel Zwaan, Prof. Dr.

  Head Trial and Data Center

  STUDY DIRECTOR

Central Study Contacts

Renske Benedictus

CONTACT

+31889727272; CHIP-AML22@prinsesmaximacentrum.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 16, 2023
• Study Start: July 14, 2023
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): December 1, 2035
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Primary CSRs may be completed earlier when the primary objective is completed and may be followed by a final CSR not later than 6 months after the end of the trial.
• Access Criteria: A summary of the study results will be made public via clinicaltrials.gov as well as to Ethical committees/ Health Authorities and all participating patients by providing them through their treating physicians a patient letter with a summary of the results.

Locations

NL (1)