A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination With Ruxolitinib for the Treatment of Intermediate- or High-Risk Myelofibrosis (MF)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pathologically confirmed diagnosis of primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF, according to the 2008 revised World Health Organization criteria
Intermediate-1, intermediate-2, or high-risk according to the IWG-MRT Dynamic International Prognostic Scoring System
Life expectancy \>= 6 months
Peripheral blood blast count of less than (\<) 10%
Palpable splenomegaly of greater than (\>) 5 centimeters (cm) below the left costal margin
Eastern Cooperative Oncology Group performance status of 0 to 2
Adequate hepatic and renal function
You may not be if
Prior treatment with a Hedgehog or Janus kinase pathway inhibitor
Treatment with strong cytochrome P450 3A4 inhibitors/inducers within 28 days prior to Day 1
Prior therapy for the treatment of intermediate- or high-risk MF including chemotherapy, interferon, thalidomide, busulfan, lenalidomide, anagrelide, or androgens within 28 days prior to Day 1
Prior splenectomy or splenic irradiation
Inadequate bone marrow reserve
Participants with any history of platelet counts of \< 50,000/mccL or ANC of \< 500/mL, except during treatment for myeloproliferative neoplasm or treatment with cytotoxic therapy for any other reason
Planned allogeneic bone marrow transplant during the study
Clareo Health | A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination With Ruxolitinib for the Treatment of Intermediate- or High-Risk Myelofibrosis (MF)
