|
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 |