MedTrace Logo

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

NCT05994690 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 905

Last updated 2025-08-05

No results posted yet for this study

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

Interventions

DRUG

Standard Intervention Rc

3 consolidation courses (HAM + HA3E + FLA)

DRUG

Investigational Intervention Rc

2 consolidation courses (HAM + FLA)

DRUG

Standard Intervention Ri

No addition of GO to first induction course

DRUG

Investigational Intervention Ri

Addition of GO to first induction course

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Princess Maxima Center for Pediatric Oncology

    lead OTHER

Principal Investigators

  • Gertjan Kaspers, Prof. Dr. · Pediatric Oncologist

  • Michel Zwaan, Prof. Dr. · Head Trial and Data Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2031-03-31
Completion
2035-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05994690 on ClinicalTrials.gov