This is an open-label, multicenter clinical study in order to collect and examine data concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 weeks
Charge in Spleen Size From Baseline at Specified Week
Number of patients with spleen length reduced by ≥ 50% at specified week
Time frame: Baseline, 24 weeks
Charge in Spleen Size From Baseline up to the Specified Week
Number of patients with spleen length reduced by ≥ 50% up to specified week
Time frame: Baseline, 24 weeks
Summary of Total Symptom Score as Measured by Seven-day Modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 by Time
The modified MFSAF v2.0 diary captures a patient's symptom severity on a scale of 0 (absent) to 10 (worst imaginable),with a maximal summary score of 60
Time frame: 24 weeks
Summary of Summary of EORTC QLQ-C30 Responses by Time
The QLQ-C30 version 1.0 (QLQ-C30) incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: 24 weeks
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Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Akita, Akita, Japan
Novartis Investigative Site
Matsuyama, Ehime, Japan
Novartis Investigative Site
Tōon, Ehime, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kurume, Fukuoka, Japan
Novartis Investigative Site
Gifu, Gifu, Japan
Novartis Investigative Site
Maebashi, Gunma, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
...and 19 more locations