ICC APL 02 (Acute Promyelocytic Leukemia)
Active, not recruiting
Who can enter
Children with newly diagnosed Acute Promyelocytic Leukemia (APL)
Age: younger than 18 years old
Goal
Goal
The goal of this study is to evaluate the safety and efficacy of the use of a combination of the medicines ATRA and ATO in the treatment of children with APL.
For children in the High Risk group we will also add the medicine GO to the beginning of their treatment.
Background
Background
APL is a type of Acute Myeloid Leukemia where there is a shortness of normal blood cells, and an abnormal accumulation of immature white blood cells called promyelocytes.
APL can be very well treated with a combination of a certain kind of chemotherapy and a medicine called ATRA. Approximately 80% of the children with APL is cured with this treatment. However, this treatment gives many side effects.
Many adult patients have already been treated successfully with a combination of the medicines ATRA (a medicine derived from vitamin A) and ATO (arsenic trioxide). This treatment approach without chemo, with only ATRA and ATO, has been studied in only a few children.
Children with a low level of white blood cells in their blood at diagnosis (Standard Risk Group, SR-APL) will be treated with a combination of ATRA and ATO.
In children with a high level of white blood cells in their blood at diagnosis (High-Risk Group, HR-APL) treatment with ATRA and ATO alone is not sufficient. For these children the medicine GO (gemtuzumab ozogamicin) will be added in the beginning of the treatment.
In this study we will evaluate if this treatment approach is also successful in the treatment of children and adolescents, and will give less side effects.
Last reviewed
Last reviewed
March 20, 2026
Study details
- Study details
Official title
ICC-APL02: Treatment study for children and adolescents with Acute Promyelocytic LeukemiaCancer type
Acute Promyelocytic Leukemia (APL)Phase
3Maximum number of patients
SR-APL: 46, of whom 2-3 are expected to participate in the Netherlands
HR-APL: 43, of whom 1-2 are expected to participate in the NetherlandsStart date
July 7, 2023Status
Closed for inclusionLocal principal investigator
Prof. dr. G.J.L. KaspersSponsor
Italian Association of Pediatric Hematology Oncology (AIEOP)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: 2017-002383-40
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.