Our website uses cookies. We use cookies to remember settings and to help provide you with the best experience we can. We also use cookies to continuously improve our website by compiling visitor statistics. Read more about cookies

Approved clinical trials

For a complete overview of all open studies at the Princess Máxima Center we would like to refer you to the SKION website. You will find lists of studies approved bij the Biobank, Data Access Committee and CRC below.

CRC number

Date of approva

Short title

Title

PI

2018-001

11-09-2018

VALID II

Pharmacokinetics of a new pediatric formulation of vala-cyclovir used for prophylaxis and treatment of VZV and HSV infections in children, phase II (VALID II)

Dr. Lindemans

2018-002

15-1-2019

Nivolumab ALCL

Phase II trial of nivolumab for pediatric and adult relapsing/refractory ALK+ anaplastic large cell lymphoma, for evaluation of response in patients with progressive disease (Cohort 1) or as consolidative immunotherapy in patients in complete remission after relapse (Cohort 2)

Dr. Beishuizen

2018-004

12-02-2019

KIZZ

Visual impairment in children with a brain tumor in the Netherlands: a prospective nationwide study using standard visual testing and optical coherence tomography

Dr. Schouten-van Meeteren

2018-005

11-09-2018

Pain monitoring

Reduction of pain in children suffering from cancer, by using an internet-based pain monitor

Dr. Michiels

2018-006

23-10-2018

REACH 4

A Phase I/II open-label, single-arm, multi-center study of ruxolitinib added to corticosteroids in pediatric patients with grade II-IV acute graft vs. host disease after allogeneic hematopoietic stem cell transplantation

Dr. Lindemans

2018-009

23-10-2018

NHL-IgA (CD20)

Testing of a new antibody therapy using blood from children with B-cell Non-Hodgkin lymphoma

Dr. Meyer-Wentrup

2018-011

12-02-2019

VERITAS

An international multicenter phase II randomised trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chemotherapy. A SIOPEN STUDY

Dr. Kraal

2018-012

06-11-2018

INFORM2 NivEnt

INFORM2 exploratory multinational phase I/II combination study of Nivolumab and Entinostat in children and adolescents with refractory high-risk malignancies

Prof. Dr. Zwaan

2018-018

12-02-2019

CASSIOPEIA

A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy

Prof. Dr. Pieters

2018-020

12-02-2019

MICADO-2

MICADO-2: Managing insomnia after childhood cancer in adolescents. Randomized controlled trial to evaluate the effect of online cognitive behavioral therapy for insomnia on sleep-efficiency and quality of life in adolescents and young adults after childhood cancer.

Dr. van Litsenburg

2018-024

12-02-2019

PKemend

Pharmacokinetics of aprepitant, dexamethasone and their interaction in children with chemotherapy induced nausea and vomiting: a pilot study

Dr. de Vos-Kerkhof

2018-025

27-11-2018

Neuroblastoma

immuno-monitoring

Deciphering the functional dynamics of the immune system during (immune)therapy in children with neuroblastoma

Dr. Nierkens

2018-027

23-10-2018

MICADO-1

Screening for insomnia and validation of PROMIS sleep item bank in adolescents after childhood cancer

Dr. van Litsenburg

2018-028

12-02-2019

Ibrutinib cGvHD

Phase 1/2 Dose Finding, Safety and Efficacy Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)

Dr. Lindemans

2018-031

12-02-2019

AC220-A-U202 Quizartinib

A phase 1/2, multi-center, dose-escalating study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Quizartinib administered in combination with the-induction chemotherapy, and as a single-agent maintenance therapy, in pediatric relapsed/refractory AML subjects aged 1 month to <18 years (and young adults aged up to 21 years) with FLT3-ITD mutations

Prof. Dr. Zwaan

2018-032

26-02-2019

CATERPILLAR

The efficacy of a lock solution containing taurolidine, citrate and heparin for the prevention of tunneled central line-associated bloodstream infections in pediatric oncology patients, a randomized controlled, mono-centre trial

Prof. Dr. Wijnen

2018-033

12-02-2019

SENSORY

Smell and Taste Dysfunction in Children with Cancer - a Feasibility Study

Dr. Tissing

2018-039

26-02-2019

IMPACT

Implementing Pediatric Advance Care Planning Toolkit

Dr. Michiels

2019-001

04-06-2019

Relapsed APL registry

International Registry for Relapsed Pediatric APL: A collaboration between Children's Oncology Group (COG) and International BFM Study Group (I-BFM-SG)

Prof. Dr. Kaspers

2019-005

18-06-2019

VUmc-DIPG01

A comprehensive and targeted therapy approach in pediatric malignant pontine gliomas

Dr. van Vuurden

2019-006

09-04-2019

Isatuximab

Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

Dr. B.J. Vormoor

2019-007

18-07-2019

THYRO-Dynamics

The THYRO-Dynamics study: Is the dynamics of thyroid hormones during cancer treatment in children adaptive or disruptive? - a propspective evaluation

Prof. Dr. van den Heuvel-Eibrink

2019-008

20-03-2019

Tracing stem cells

Single-cell tracing of genomic mutations in human hematopoietic stem cell transplantation recipients

Dr. Belderbos

2019-009

21-05-2019

OPTIMA

Evaluation of prophylactic micafungin treatment for invasive fungal diseases in children with ALL

Dr. Tissing

2019-0010

12-03-2019

BODY

Body composition of patients with neuroblastoma

Dr. Tissing

2019-0012

27-08-2019

Granylosa study

Granulosa Cell Tumours: a step towards targeted therapy

Dr. Mavinlkurve-Groothuis

2019-0013

23-04-2019

Mijn Máxima Plan

Pilotstudy of the application ‘Mijn Máxima Plan’

Prof. Dr. Grootenhuis

2019-014 26-02-2019 InO compassionate use A retrospective study on compassionate use of Inotuzumab Ozogamicin in infants and younger children with relapsed or refractory acute lymphoblastic leukemia (ALL)

Prof. dr. Zwaan

2019-016

04-06-2019

Dabrafenib AM2 and AM3

Dabrafenib amendments 2 and 3:

Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)

Dr. van der Lugt

2019-017

09-04-2019

BEACON AM11

BEACON amendment 11:

A randomised phase IIb trial of BEvACizumab added to Temozolomide ± IrinOtecan for children with refractory/relapsed Neuroblastoma.

BEACON amendment 11 for protocol version 6.0

Dr. van Eijkelenburg

2019-018

10-09-2019

7T MRI brain

Non-invasive characterization of paediatric brain tumours using metabolic imaging at high magnetic field

Dr. Plasschaert

2019-021

18-06-2019

WES-KidTs parent interviews

Parent’s understanding, views and experiences concerning genomic sequencing in a paediatric renal cancer research setting

Prof. Dr. van den Heuvel-Eibrink

2019-022

18-06-2019

rEECur

International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma

Dr. Merks

2019-023

07-05-2019

Kundig en kwetsbaar

Een zorgethische studie naar de geleefde ervaring van kinderverpleegkundigen ten aanzien van second victimhood

Anja Portengen

2019-024

09-04-2019

ENERGICE

Resting energy expenditure in children with cancer

Dr. Tissing

2019-026

10-09-2019

CHAPATI (Outreach)

Children treated with vincristine: A trial regarding pharmacokinetics, DNA and toxicity of targeted therapy in pediatric oncology patients.

Prof. Dr. Kaspers

2019-027

13-08-2019

Fosaprepitant MK0517-045

A Phase 4, Open-label, Single Arm Study to Evaluate the Safety and Tolerability of a Three-day Fosaprepitant Regimen Administered for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants Receiving Emetogenic Chemotherapy

Prof. Dr. Zwaan

2019-028

26-03-2019

UMBRELLA

UMBRELLA: Integrated research and guidelines for

standardized diagnostics and therapy

Prof. Dr. van den Heuvel-Eibrink

2019-030

16-07-2019

HR-NBL2/SIOPEN

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

Dr. Tytgat

2019-031

18-06-2019

PHITT

Paediatric Hepatic International Tumour Trial

Dr. Zsiros

2019-034

10-09-2019

FaR-RMS

FaR-RMS - An overarching study of Children and adults with Frontline and Relapsed Rhabdomyosarcoma

Dr. Merks

2019-035

18-06-2019

PNET5

An International Prospective Trial on Medulloblastoma (MB) in Children Older Than 3 to 5 Years With WNT Biological Profile (PNET 5 MB - LR and PNET 5 MB - WNT-HR), Average-risk Biological Profile (PNET 5 MB-SR), Or TP35 Mutation, and Registry For MB Occurring in the Context of Genetic Predisposition

Dr. Plasschaert

2019-036

02-07-2019

GO40871 - Idasanutlin

A Phase I/II, Multicenter, Open Label, Multi Arm Study Evaluating The Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin In Combination With Either Chemotherapy Or Venetoclax In The Treatment Of Pediatric And Young Adult Patients With Relapsed/Refractory Acute Leukemias Or Solid Tumors

Prof. Dr. Zwaan

2019-038

04-06-2019

National Rhabdomyosarcoma Registry

National Rhabdomyosarcoma Registry

Dr. Merks

2019-039

16-07-2019

Flotetuzumab - ADVL1812

A Phase 1 Trial of the CD123 X CD3 Dual Affinity Re-targeting Antibody Flotetuzumab (NSC#808294) in Children, Adolescents And Young Adults With Relapsed or Refractory Acute Myeloid Leukemia

Prof. Dr. Zwaan

2019-043

02-07-2019

Ponatinib - INCB 84344-102

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants

Prof. Dr. Zwaan

2019-044

22-07-2019

HSDQ validation

The Holland Sleep Disorder Questionnaire (HSDQ) in adolescents without a pediatric cancer diagnosis

Prof. Dr. Grootenhuis

2019-045

27-08-2019

IntReALL HR 2010

International Study for Treatment of High Risk Childhood Relapsed ALL 2010 - A randomized Phase II Study Conducted by the Resistant Disease Committee of the International BFM Study Group

Prof. Dr. Hoogerbrugge

2019-047

24-06-2019

SOUND

A prospective study on determinants of ototoxicity during treatment of childhood cancer (the SOUND study)

Prof. Dr. van den Heuvel-Eibrink

2019-048

18-06-2019

Craniopharyngioma Cohort study

The Dutch Childhood Craniopharyngioma Cohort study

Prof. Dr. Tissing

2019-051

27-08-2019

RELIEF-1

Reducing Pain in Pediatric Oncology Patients at Home. A Feasibility Study of the KLIK painmonitor (RELIEF-1)

Prof. Dr. Tissing

2019-053

30-07-2019

AMoRe 2017

International Multi-center, Open-label, Phase 2 Study to Treat Molecular Relapse of Pediatric Acute Myeloid Leukemia with Azacitidine

Prof. Dr. Zwaan

2019-054

16-07-2019

EMBRACE

Ervaringen van zorgprofessionals met verlies- en rouwzorg aan ouders rondom het levenseinde van hun kind

Prof. Dr. Grootenhuis

2019-057

10-09-2019

SeluDex

SeluDex: an international phase I/II expansion trial of the MEK inhibitor selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult Acute Lymphoblastic Leukaemia (ALL)

Dr. B.J. Vormoor

2019-059

27-08-2019

ALLTogether-1

ALLTogether1 - A Treatment study protocol of the ALLTogether Consortium for children and young adults (1-45 years of age) with newly diagnosed acute lymphoblastic leukaemie (ALL)

Dr. van der Sluis