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A Phase I/II study of Brigatinib in pediatric and young adult patients with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other solid tumors

This study has been transitioned to CTIS with ID 2024-513412-10-00 check the CTIS register for the current data. Phase 1: • To determine the MTD/RP2D regimen of brigatinib monotherapy when administered in pediatric and AYA patients with ALK+ ALCL or…

Minimal residual disease in peripheral blood compared to bone marrow in patients treated for acute myeloid leukemia

Our research aims to determine and compare MRD in BM and PB with our current qualified MRD test. The study takes place in at the Amsterdam UMC location VUmc. We take two extra tubes (14 ml total) of heparin blood at the same day as the planned BM…

A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML

This study has been transitioned to CTIS with ID 2023-510160-12-00 check the CTIS register for the current data. To assess if venetoclax combined with FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall…

Determination of reference values: numbers, repertoire and products of leukocytes in immunological healthy elderly

Generation of (age-dependent) reference values **of leukocytes and their subtypes and of their products, as well as analysis of (age-dependent) IG / TR repertoire. In order to be able to distinguish the age-dependent effects from effects caused by…

A RANDOMIZED, DOUBLE-BLINDED, DOUBLE-DUMMY, PLACEBO-CONTROLLED THOROUGH QTC STUDY WITH SINGLE ORAL DOSES OF CEDAZURIDINE IN HEALTHY SUBJECTS

The purpose of the study is to investigate the effect of cedazuridine on the values of specific electrocardiogram (ECG) parameters. One of these parameters is the QT -interval. The QT -interval indicates the recovery time of the heart muscle cells…

A Modular, Multipart, Multi-arm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of EP0042 Alone and in Combination with Anti-cancer Treatments in Patients with Advanced Malignancies

This study has been transitioned to CTIS with ID 2024-514588-24-00 check the CTIS register for the current data. Core Primary Objectives:1. To investigate the safety and tolerability of EP0042 given alone or in combination with anti-cancer…

A Phase 3, Randomized, Double-blind, Active-Control Study of pelabresib (CPI0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

This study has been transitioned to CTIS with ID 2023-507954-34-00 check the CTIS register for the current data. Primary• To determine the efficacy of pelabresib + ruxolitinib compared with placebo + ruxolitinibKey Secondary• To determine the effect…

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

This study has been transitioned to CTIS with ID 2024-513759-34-00 check the CTIS register for the current data. Primary ObjectivesPhase 2The primary objectives of Phase 2 are:• To evaluate short- and long-term safety and tolerability of SNDX 5613…

Phase III Clinical Trial for CPX-351 in Myeloid Leukemia in Children with Down Syndrome 2018

This study has been transitioned to CTIS with ID 2022-501457-37-00 check the CTIS register for the current data. Primary Objective:- Achieving an event-free survival, which is not inferior to the ML-DS 2006 trial (87±3%)Secondary Objective(s):-…

A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Primary:To compare the efficacy of asciminib versus Investigator selected TKI with respect to the proportion of patients that are in Major Molecular Response at Week 48. To compare the efficacy of asciminib versus Investigator selected TKI, within…

Monitor immune microenvironment and systemic immune effects in pediatric oncology

Brain tumors: Characterize and quantify changes in immune parameters during disease in patients with a CNS malignancyAML: Characterize and quantify changes in immune parameters and immunotherapeutic targets during disease in pediatric patients with…

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B-cell Malignancies

This study has been transitioned to CTIS with ID 2024-511267-28-00 check the CTIS register for the current data. To evaluate the long-term safety of zanubrutinib in patients with B-cell cancers who participated in a BeiGene parent study for…

An alternating panel, single ascending dose trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, relative bioavailability, and food effect of orally administered AS-1763 in healthy subjects

In this study we will investigate how safe the new compound AS-1763 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent AS-1763 is absorbed, transported, and eliminated from the…

An open-label study to investigate the effects of emvododstat on the pharmacokinetics of CYP2D6 and BCRP substrates in healthy volunteers

In this study, we will investigate what the effect of the new compound emvododstat is on how quickly and to what extent 2 approved medications (dextromethorphan in Part 1 and rosuvastatin in Part 2) are absorbed, transported, and eliminated from the…

A phase 1 trial to assess P-gp mediated drug interactions with ASTX660 in healthy volunteers

The main purpose of this study is to investigate the effect of ASTX660 on how quickly and to what extent quinidine and fexofenadine are absorbed, distributed, broken down and eliminated from the body. Quinidine and fexofenadine have been chosen…