Myeloproliferative Neoplasms Clinical Trial
Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)
Summary
To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.
Eligibility Criteria
Inclusion Criteria:
Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy
Discontinuation of all drugs used to treat underlying MF disease at least 14 days prior to baseline visit
INR <= 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry
Hemoglobin level at least 6.5 g/dL at Screening visit
Willingness to be transfused to treat low hemoglobin levels
Exclusion Criteria:
Females who are pregnant, unable to comply with birth control use to avoid becoming pregnant or breastfeeding
Males who cannot comply with birth control use to avoid fathering a child
Platelet count < 50 x10^9/L or absolute neutrophil count (ANC) < 1 x10^9/L at the Screening visit
Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (INR) laboratory values cannot be > 1.5 x upper limit of normal at study entry.
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There is 1 Location for this study
Birmingham Alabama, , United States
Beverly Hills California, , United States
Burbank California, , United States
La Jolla California, , United States
Los Angeles California, , United States
Pomona California, , United States
San Diego California, , United States
New Haven Connecticut, , United States
Fort Myers Florida, , United States
Jacksonville Florida, , United States
Orange City Florida, , United States
Atlanta Georgia, , United States
Augusta Georgia, , United States
Chicago Illinois, , United States
Iowa City Iowa, , United States
Louisville Kentucky, , United States
New Orleans Louisiana, , United States
Baltimore Maryland, , United States
Ann Arbor Michigan, , United States
Southfield Michigan, , United States
Saint Louis Missouri, , United States
Hackensack New Jersey, , United States
Morristown New Jersey, , United States
Somerville New Jersey, , United States
New York New York, , United States
Durham North Carolina, , United States
Hickory North Carolina, , United States
Canton Ohio, , United States
Cleveland Ohio, , United States
Portland Oregon, , United States
Danville Pennsylvania, , United States
Hershey Pennsylvania, , United States
Charleston South Carolina, , United States
Nashville Tennessee, , United States
Houston Texas, , United States
San Antonio Texas, , United States
Salt Lake City Utah, , United States
Burlington Vermont, , United States
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