CHIP-AML22/Master (Acute Myeloid Leukemia)

Clinical study concerning the treatment of children and adolescents with newly diagnosed acute myeloid leukemia (AML).

Recruiting

Who can enter

Children and adolescents with newly diagnosed acute myeloid leukemia (AML)
Age: 0 up to and including 18 years

Goal

The goal of this study is to investigate whether the treatment of children and adolescents with CML can be improved by:

An improved risk-group classification for treatment
The addition of extra treatment options for specific groups

Background

Treatment of AML consists of intensive chemotherapy and in some cases also stem cell transplantation. To determine the exact treatment, patients are divided in different treatment groups, the so called ‘risk groups’. We determine the risk group by, among others, looking at the characteristics of AML cells at diagnosis and how the disease responds at the start of treatment.

The treatment protocol that was used until now for children and adolescents with AML showed good results: 70-80% of the children survives the disease with this treatment. When the disease fails to respond to the treatment, or comes back later, the prognosis is worse. Therefore, it is important to prevent the AML from not responding or from coming back.

In this new study, the treatment given is in general similar to what we did before. Based on results from previous studies, we are now able to better identify the characteristics that determine the risk group for treatment. In addition, we want to add extra treatment options for specific groups to the standard treatment. We hope to improve the treatment in this way.

This scientific study is initiated by the NOPHO-DB-SHIP consortium (a collaboration of 14 different countries in- and outside Europe) and is being performed in several hospitals. In the Netherlands, the study is performed in the Princess Máxima Center for pediatric oncology.

Substudy

In order to participate in a study please refer to your/your child’s doctor.
For international patients: please feel welcome to contact our International Patients Office.

Last reviewed

July 14, 2023

Study details
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
Cancer type
Acute Myeloid Leukemia (AML)
Phase
3
Maximum number of patients
905, of whom 120 are expected to participate in the Netherlands
Start date
July 14, 2023
Status
Open
Local principal investigator
Dr. B.F. Goemans
Sponsor
Princess Máxima Center for pediatric oncology
Approval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.
Trial registry number
EU Clinical Trials Register: 2022-002885-34

The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.