Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis

Completed · Phase 2

Conditions studied: Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis

In brief

The purpose of this study was to evaluate the effect of an alternative dosing strategy of ruxolitinib in subjects with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) and post essential thrombocythemia-myelofibrosis (PET-MF) in order to minimize the development of anemia and thrombocytopenia.

Key facts

Study ID

NCT01445769

Run by

Incyte Corporation

People needed

45

Starts

2011-09-01

Expected to finish

2013-04-01

Last updated by the study team

2019-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) as confirmed by bone marrow biopsy.
• Must score at least 2 points on the Dynamic International Prognostic Scoring System (DIPSS) scale for prognostic risk factors.
• Peripheral blast count < 5% at both Screening and Baseline hematology assessments.
• Must discontinue all drugs used to treat underlying myelofibrosis (MF) disease no later than Day -1 (the day prior to starting ruxolitinib).
• Must have hemoglobin value ≥ 6.5 g/dL and be willing to receive blood transfusions.
• Platelet count ≥ 100*10\^9/L.
• Must have a palpable spleen.

You may not qualify if…

• Inadequate liver or bone marrow reserves, end stage renal disease on dialysis, clinically significant concurrent infections requiring therapy, or unstable cardiac function.
• Invasive malignancies over the previous 5 years (except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, and completely resected papillary thyroid and follicular thyroid cancers).
• Splenic irradiation within 6 months prior to receiving the first dose of study medication.
• Life expectancy less than 6 months.

Where it is running

• Study site — Highland, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Iowa City, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Southfield, Michigan, United States
• Study site — Morristown, New Jersey, United States
• Study site — Armonk, New York, United States
• Study site — Hickory, North Carolina, United States
• Study site — Canton, Ohio, United States
• Study site — Hazleton, Pennsylvania, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Sioux Falls, South Dakota, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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