Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF)
|Myeloproliferative Diseases||Drug: Ruxolitinib Drug: Pracinostat Behavioral: Questionnaire||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Evaluation of Ruxolitinib and Pracinostat Combination as a Therapy for Patients With Myelofibrosis|
- Objective Response Rate (ORR) [ Time Frame: 3 months ]Objective response rate (ORR), defined as a clinical improvement (CI), partial remission (PR), and complete remission (CR) according to the International Working Group (IWG) Criteria.
- Toxicity of Combination of Ruxolitinib with Pracinostat [ Time Frame: 3 months ]Toxicity defined as Grade 3-4 clinically relevant non-hematologic toxicity or a serious adverse event that is at least possibly related to the study drug (Common Terminology Criteria for Adverse Events CTCAE version 4.0).
|Actual Study Start Date:||January 12, 2015|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: Ruxolitinib + Pracinostat
Ruxolitinib starting dose 15 mg orally twice/day in 28-day cycle (dose assigned based on platelet count, if low platelet count gradual up-titration from a starting dose of 5 mg) - given alone for first 3 months, then Pracinostat added at starting dose 60 mg orally once/day for 3 alternating days every 3 weeks starting Day 1 of Cycle 4.
Dose of Ruxolitinib may be increased or decreased prior to initiation of Pracinostat. Quality of Life Questionnaire.
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.
Other Names:Drug: 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.Behavioral: Questionnaire
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.
Other Name: Survey
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02267278
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Srdan Verstovsek, MD||M.D. Anderson Cancer Center|