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Zwaan group

Early drug development

Our research program includes translational research projects in pediatric leukemia, with a special focus on experimental therapeutics/early drug development. The objective is to register new drugs for children with cancer so that they can be prescribed in the healthcare setting.

Contact

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Michel Zwaan

As a pediatric oncologist, I am mainly concerned with the treatment of children with acute myeloid leukemia (AML) and lymphoblastic leukemia (ALL) and related pre-clinical and clinical research.

In addition, I head the Trial and Data Center of the Princess Máxima Center, together with statistician Dr. Harm van Tinteren, where I provide the medical expertise. I am chair of the Dutch Society of MRECs (in Dutch:  NVMETC). I also chair the hematological malignancies committee of ITCC (phase 1-2 pediatric oncology network in Europe), for which the Maxima implements many studies.

“We search for new medicines to increase survival rates and decrease toxicity”

Prof. dr. Michel Zwaan

Research group leader and pediatric oncologist

Pre-clinical research

The research program on myeloid leukemias is done in close collaboration with group leaders in the Princess Máxima Center, including the Stam group, the Van Boxtel group and the Heidenreich group. The program focuses on identifying determinants of clinical outcome to improve risk-group stratification, and to identify novel options for targeted treatment. Down ALL projects are performed in close collaboration with the Den Boer group.

Close collaboration exists with Dr. Soheil Meshinchi from the Children’s Oncology Group (Seattle, USA), and Prof. Jan Henning Klusmann from the AML-BFM Group (Frankfurt, Germany), as well as with the International-BFM Study Group AML committee. 

PhD students - Pre-clinical research

Clinical Research

The early clinical trial program includes clinical studies of promising novel agents for children with cancer, and in addition focuses on therapeutic drug monitoring, bioequivalence studies of pediatric-friendly formulations, and age-dependent pharmacokinetics/dynamics.

This includes looking at new drugs developed under a Pediatric Investigational Plan of the EMA or under a commitment to the FDA. The following studies, involving Prof. Dr. Michel Zwaan as principal investigator, are currently ongoing in this context:

  • Inotuzumab ozogamicin (phase 1 and 2 studies in children with ALL)

  • Bosutinib (phase 1 and 2 studies in children with CML)

  • Crizotinib (a phase 4 study of dosing and toxicity of this drug as part of a registration requirement)

  • Brigatinib (a phase 1/2 study in children with solid tumors and large cell anaplastic lymphoma)

  • Venetoclax (a phase 3 study in children with relapsed AML)

  • Ziftomenib (a phase 1 study in children with relapsed AML with specific genetic abnormalities)

Drug approvals

Based on the first two studies, the FDA recently approved bosutinib for the treatment of newly diagnosed and resistant/intolerant children over 1 year of age with CML (September 2023), and inotuzumab ozogamicin for the treatment of children over one year of age with relapsed/refractory CD22-positive ALL (March 2024). These approvals were obtained after transfer of the data obtained in these intent-to-file academic studies to the pharma company, who submitted the dossier to the regulatory authorities for assessment. Approval for inotuzumab ozogamicin was also obtained from the Japanese health authorities (March 2024). The European Medicines Agency also approved bosutinib for children in June 2025 while assessment of inotuzumab is ongoing.

In addition, the Trial and Data Center is closely involved in two new leukemia studies initiated from the Máxima:

  • The CHIP-AML study for newly diagnosed children with AML. As a subtrial, this involves studying quizartinib in FLT3 mutated patients as part of a pediatric investigational plan (principal investigator Prof. Dr. Gertjan Kaspers).

  • The Interfant-21 study, studying blinatumomab (principal investigators Dr. Janine Stutterheim and Prof. Dr. Rob Pieters).

PhD students and clinical scientists

Clinical trial units

Grants, awards and publications

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