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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 approval

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

2019-014 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