At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Ruxolitinib and Pracinostat Combination as a Therapy for Patients With Myelofibrosis
In Brief
A Phase 2 clinical trial evaluating Ruxolitinib, Pracinostat, and 1 other intervention for Myeloproliferative Diseases. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if pracinostat, when given in combination with ruxolitinib, can help to control myelofibrosis (MF). The safety of this drug combination will also be studied. This is an investigational study. Pracinostat is not FDA-approved or commercially available. It is currently being used for research purposes only. Ruxolitinib is FDA-approved and commercially available to treat MF. The study doctor can explain how the study drugs are designed to work. Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.
Study Details
Timeline
Interventions
Ruxolitinib taken by mouth 2 times each day in a 28-day cycle. Patients receive Ruxolitinib alone for first 3 months, and then Pracinostat added. Starting dose of Ruxolitinib based on patients' platelet count. Dose of Ruxolitinib may be increased or decreased at discretion of treating physician prior to initiation of Pracinostat.
Starting dose of Pracinostat 60 mg by mouth 1 time each day for 3 alternating days every 3 weeks starting on Day 1 of Cycle 4.
Questionnaire regarding quality of life completed at baseline, within 3 days before Day 1 of Cycles 1 - 6, and then every 3 cycles after that.