ArticleTrials2026
CHIP-AML22: a complex clinical trial in de novo pediatric AML patients, including a gemtuzumab ozogamicin randomization and targeted therapy with quizartinib in eligible subgroups, within the NOPHO-DB-SHIP consortium.
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An Open Label Complex Clinical Trial in Newly Diagnosed Pediatric de Novo AML Patients - a Study by the NOPHO-DB-SHIP Consortium, Master Protocol
A Phase II, Single Arm, Open Label, Study on the Safety, Efficacy, Pharmacokinetics & Pharmacodynamics of Quizartinib + Chemotherapy and as Single-agent After High Dose Therapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients
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30 authors.
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Abstract
backgroundThe overall survival of children with newly diagnosed acute myeloid leukemia (AML) in high-income countries has increased to 80% over the past decades. Nevertheless, a significant subset of patients experiences relapse and treatment is associated with both short- and long-term toxicities. The CHIP-AML22 protocol includes an updated standard-of-care treatment for children with AML within the NOPHO-DB-SHIP consortium. Targeted therapies are offered to specific subsets of patients and measures to reduce toxicity are being investigated.
methodsCHIP-AML22 is a multinational complex clinical trial in newly diagnosed de novo AML patients up to and including 18 years of age, sponsored by the Princess Máxima Center. The primary aim is to improve event-free survival. To achieve this, (1) FLT3-ITD+/NPM1wt patients can participate in a linked-trial assessing safety and efficacy of quizartinib, in addition to conventional chemotherapy during induction and consolidation therapy and as continuation monotherapy after allogeneic hematopoietic stem cell transplantation; (2) a randomization study is incorporated on the use of two doses of 3 mg/m DISCUSSION: The risk-based approach and use of targeted therapies in CHIP-AML22 illustrate a shift toward more personalized treatment. Besides improving event-free survival, this study aims to contribute to the international consensus on strategies to reduce toxicity for all patients. The design of this study provides a dynamic framework, allowing for the potential introduction of emerging therapeutic options in the future.
trial registrationCHIP-AML22 Master protocol: EU CT 2023-504999-25-00, Clinicaltrials.gov NCT05994690. Registered on 16-08-2023 Quizartinib linked-trial: EU CT 2023-505000-27-01, Clinicaltrials.gov NCT06262438. Registered on 16-02-2024.
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