A Phase I Study of Ruxolitinib Plus Abemaciclib for Patients With Primary or Post-polycythemia Vera/Essential Thrombocythemia Myelofibrosis
Memorial Sloan Kettering Cancer Center
Summary
The study is being done to see if the combination of ruxolitinib and abemaciclib is a safe and effective treatment for people with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with PMF or post-PV/ET MF requiring therapy and intermediate-1, -2 or high risk disease by the Dynamic International Prognostic Scoring System (DIPSS) , DIPSS-plus MIPSS7021 or MIPSS70-plus v2.0 if PMF and by the Myelofibrosis Secondary to PV and ET - Prognostic Model (MYSEC-PM) if post-PV/ET MF * Treated with ruxolitinib for ≥12 weeks with a stable dose for the preceding ≥4 weeks. Patients must be on a dose of ruxolitinib of 10mg or 15mg BID at the time of screening. * Evidence of inadequate response to ruxolitinib: Patients must have palpable splenomegaly ≥5 c…
Interventions
- DrugRuxolitinib
10mg BID or 15mg BID
- DrugAbemaciclib
50, 100 and 150 mg
Locations (7)
- Memorial Sloan Kettering Basking RidgeBasking Ridge, New Jersey
- Memorial Sloan Kettering MonmouthMiddletown, New Jersey
- Memorial Sloan Kettering BergenMontvale, New Jersey
- Memorial Sloan Kettering Suffolk - CommackCommack, New York
- Memorial Sloan Kettering WestchesterHarrison, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York