The aim of the present study is to evaluate the efficacy and safety of MK-0683 in the treatment of PV and ET. This agent has most recently been shown to be a potent inhibitor of the autonomous proliferation of haematopoietic cells of PV and ET patients carrying the JAK2 V617F mutation. Accordingly, it may be anticipated that MK-0683 - by decreasing the JAK2 allele burden - may influence clonal myeloproliferation and in vivo granulocyte, platelet and endothelial activation , which are considered to be major determinants of morbidity and mortality ( thrombosis, bleeding, extramedullary haematopoiesis , myelofibrosis ) in these disorders. The effects of MK-0683 at the molecular level will be studied by global/ focused gene expression profiling, epigenome profiling and proteomics.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
400 mg once daily for 6 months
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Esberg Hospital
Esbjerg, Denmark
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark
Roskilde Hospital
Roskilde, Denmark
Regional Hospital Viborg
Viborg, Denmark
VU University Medical Centre
Amsterdam, Netherlands
University Hospital Orebro
Örebro, Sweden
Stockholm South General Hospital (Sodersjukhuset)
Stockholm, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
...and 6 more locations
To evaluate the efficacy of study drug (MK-0683) in the treatment of patients with PV and ET.
Time frame: one year
To study changes in bone marrow morphology before and after treatment with study drug.
Time frame: one year
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