RecruitingPhase 3NCT05994690

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

An Open Label Complex Clinical Trial in Newly Diagnosed Pediatric de Novo AML Patients - a Study by the NOPHO-DB-SHIP Consortium, Master Protocol


Sponsor

Princess Maxima Center for Pediatric Oncology

Enrollment

905 participants

Start Date

Jul 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 DayMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a complex pediatric cancer trial testing new treatment approaches for children and teenagers newly diagnosed with acute myeloid leukemia (AML), a type of blood cancer that starts in the bone marrow. **You may be eligible if...** - Your child is from newborn age up to 18 years old - Your child has been newly diagnosed with AML (not caused by prior chemotherapy or bone marrow failure) - Your child has not received any prior AML treatment - Parents or legal guardians can provide written consent (and the child can give assent if appropriate) **You may NOT be eligible if...** - Your child has a different type of leukemia or a secondary (treatment-related) AML - Your child has previously been treated for AML - Consent/assent requirements are not met Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStandard Intervention Rc

3 consolidation courses (HAM + HA3E + FLA)

DRUGInvestigational Intervention Rc

2 consolidation courses (HAM + FLA)

DRUGStandard Intervention Ri

No addition of GO to first induction course

DRUGInvestigational Intervention Ri

Addition of GO to first induction course


Locations(1)

Princess Máxima Center for pediatric oncology

Utrecht, Utrecht, Netherlands

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NCT05994690


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