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Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)

Status
Completed
Cancer Type
Hematopoietic Malignancies
Leukemia
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT01348490
Protocol IDs
INCB18424-258 (primary)
Study Sponsor
Incyte Corporation

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

  1. Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy
  2. Discontinuation of all drugs used to treat underlying MF disease at least 14 days prior to baseline visit
  3. INR <= 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry
  4. Hemoglobin level at least 6.5 g/dL at Screening visit
  5. Willingness to be transfused to treat low hemoglobin levels

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

Study Coordinator:
Wilena Session
404-778-5319

Doctors:

Martha L. Arellano MD
Elliott F. Winton MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.