|
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 |
