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A Phase 2, multicenter, open-label study to evaluate the pharmacokinetics, pharmacodynamics,
safety and activity of azacitidine and to compare azacitidine to historical controls in pediatric
subjects with newly diagnosed advanced myelodysplastic syndrome or juvenile myelomonocytic
leukemia before hematopoietic stem cell transplantation

The primary objective is to assess the treatment effect on response rate (MDS: either completeremission [CR], partial remission [PR], or marrow CR; JMML: either clinical completeremission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28…

Effectiveness of lipofilling in patients with impaired speech and/or swallowing function after treatment for head and neck cancer

The primary objective of this study is to evaluate the effectiveness of lipofilling in treatment of speech and swallowing impairment after treatment for head and neck cancer. The secondary objective is to evaluate the effect of lipofilling on tongue…

Metformin and sitagliptin in patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke - safety and feasibility

We aim to compare the effectiveness, feasibility and safety of both metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. Furthermore, we will assess whether a slow increase in dose of metformin over…

A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment.
The ReCab trial

Primary objectives:To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with Cabazitaxel in order to proceed with a Randomised Phase 2 trial designed to determine the clinical value of Rhenium-…

A Randomized, Controlled Phase 2 Study Evaluating LY2875358 plus Erlotinib versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Activating EGFR Mutations Who Have Disease Control after an 8-Week Lead-In Treatment with Erlotinib

The primary objective of this study is to compare PFS with LY2875358 plus erlotinib therapy with erlotinibmonotherapy as first-line treatment in metastatic NSCLC patients with activating EGFR mutations who havedisease control after an 8-week lead-in…

A phase II multicenter, single-arm study of MPDL3280A in patients with PD-L1 positive locally advanced or metastatic non small cell lunch cancer

The primary efficacy objective for this study is to evaluate the efficacy of MPDL3280Ain patients with PD-L1*positive locally advanced or metastatic NSCLC, as measuredby investigator-assessed ORR according to modified RECIST.SECONDARY OBJECTIVESThe…

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged >= 66 years .

Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of selinexor added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…

Randomized Phase II, 2-arm study of Pembrolizumab after high dose radiation (SBRT) versus Pembrolizumab alone in patients with advanced non-small cell lung cancer.

Primary objective:To observe an increase in Overall Response Rate (ORR) from 20% in the pembrolizumab alone arm to 50% in the pembrolizumab after SBRT arm at 12 weeks. Secondary Objective: - Disease Control Rate, defined as the percentage of…

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group
Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of
Subjects with Moderate to Severely Active Crohn*s Disease

To evaluate the safety and efficacy of intravenously administered FFP104 in subjects with active Crohn*s disease following repeat doses of FFP104.

Transarterial Chemoembolization with Drug-Eluting Beads (standard arm) versus Stereotactic Body Radiation Therapy (experimental arm) for hepatocellular carcinoma:
A multicenter randomized phase II trial *The TRENDY trial*

To assess the time to progression after TACE-DEB and after SBRT in a comparable population of patients diagnosed with HCC.

Efficacy and safety of an innate allogeneic haematopoietic stem cells transplantation
in patients with haematological malignancies

To test transplantation-related mortality after an innate allo-SCT defined as alpha/beta T-cell depleted stem cell support combined with a *low dose DLI*.

Node study: 'Esophageal resection for patients with esophageal cancer and cervical lymph node metastases'

To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases in level III and/ or…

A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction and consolidation for patients with progressive or refractory Multiple Myeloma.

Part I: Evaluate the safety and tolerability of selinexor at 3 different dose levels in combination with bortezomib/dexamethasone & determine recommended dose level (RDL) of selinexor for Part IIPart II: Evaluate the efficacy of the…

Ga-68-DOTA-(RGD)2 PET/CT: imaging angiogenesis in patients with low-flow vascular malformations

The primary objective of this study is to measure whether αvβ3 integrin expression and tracer uptake values of 68Ga-DOTA-(RGD)2 change in patients with (recurrent) low-flow vascular malformations after embolization therapy.

CRP-POCT in suspected airway infected patients in the long-term care facility

The main objective is to investigate the additional value of CRP-POCT (C-reactive protein point-of-care-test) testing in patients suspected of airway infections in long-term care facilities.

Internet-delivered cognitive behavioral therapy for posttraumatic stress disorder in humanitarian aid workers: a pilot study

Primary objectives: 1. To translate and adapt the iCBT program TELLUS for use in IFRC humanitarian aid workers2. To determine feasibility of TELLUS in terms of: completion rates and self-reported treatment credibility/ expectancySecondary objective:…

Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin*s lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy.

To assess the feasibility and efficacy of 90Y-ibritumomab tiuxetan consolidation treatment after R-PECC chemotherapy as second or third line treatment in patients with refractory or relapsed aggressive B-cell NHL, after or not eligible for…

Irreversible Electroporation for treatment of unresectable, locally advanced pancreatic cancer in the Leiden University Medical Centre: a phase I/II study.

Main objectiveTo investigate feasibility and safety of tumor ablation using IRE in patients with irresectable locally advanced pancreatic head carcinomas.Secondary objective(s)To investigate tumor downstaging efficacy, pain perception and hospital…

Double umbilical cord blood transplantation in high-risk haematological patients.
A phase II study focussing on the mechanism of graft predominance

Objective of the study is to evaluate whether parameters can be identified that predict which graft ultimately prevails following cord blood transplantation after a reduced intensity conditioning regimen in adult patients .In addition engraftment,…

Nutritional Route In Esophageal Resection trial

This study aims to determine whether early start of oral intake in patients that underwent an esophagectomy is feasible and safe.