Myelofibrosis
Conditions
Interventions
Sponsors
The Forth Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, male or female 2. ECOG PS score of physical condition: 0-2 points 3. Patients diagnosed with primary myelofibrosis (PMF) according to WHO standard (2016) or patients diagnosed with MF after polycythemia vera (Post-PV-MF) or MF after primary thrombocytosis (Post-ET-MF) according to IWG-MRT standard 4. According to the DIPSSDIPSS-plusMIPSS-70 or MIPSS-70 2.0,patients with low-risk primary myelofibrosis were evaluated; Or according to the prognosis model of ET and PV secondary myelofibrosis (MYSEC-PM), patients with low-risk secondary myelofibrosis were evaluated According to the age (>= 67 years old is 5 points, 57~66 years old is 2 points), wbc>15*10^9/l (1 point), venous thrombosis (1 point), after the prognosis evaluation, the score = 1 point, belonging to the medium-risk group or high-risk group; 5. Expected survival period > 24 weeks 6. Subjects fully understand and voluntarily participate in this study and sign informed consent 7. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the program requirements
Exclusion criteria
Exclusion criteria: 1. Patients with incomplete follow-up data or lost follow-up during follow-up 2. The patients who had not fully recovered from surgery within 4 weeks before screening 3. Patients with grade III or above congestive heart failure (NYHA grade), uncontrollable or unstable angina pectoris or myocardial infarction, cerebrovascular accident or pulmonary embolism within 6 months before screening 4. Patients with arrhythmia requiring treatment or QTc interval (QTcB) >480ms during screening 5. Bacterial, viral, parasitic or fungal infections requiring treatment with any clinical symptoms at the time of screening 6. Combined with other serious diseases(including serious neurological or psychiatric history) 7. Patients with known or expected hypersensitivity or intolerance to the active ingredients or excipients of Ruxoltinib 8. Women in pregnancy, preparation for pregnancy or breast feeding period 9. Unsuitable subjects for this study determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy;Spleen size;Symptom score(MPN-10);Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological response;PD; | — |
Countries
China
Contacts
Public ContactJian Huang
The Forth Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed