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Efficacy and Safety of Low-dose Ruxoltinib in Patients with Lower and Intermediate Risk Polycythemia Vera ---a Single Arm, Exploratory and Prospective Study

Efficacy and Safety of Low-dose Ruxoltinib in Patients with Lower and Intermediate Risk Polycythemia Vera ---a Single Arm, Exploratory and Prospective Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064247
Enrollment
Unknown
Registered
2022-10-01
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycythemia Vera

Interventions

Sponsors

The Forth Affiliated Hospital Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old 2. Patients diagnosed with polycythemia vera (PV) according to WHO (2016) 3. 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; 4 .Expected survival time > 24 weeks;

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. Concomitant with other serious diseases, or considered unsuitable for use by the investigator.

Design outcomes

Primary

MeasureTime frame
Complete remission;Partial remission;Not responsive;Progressive disease;Event free survival;Safety;

Countries

China

Contacts

Public ContactJian Huang

The Forth Affiliated Hospital Zhejiang University School of Medicine

househuang@zju.edu.cn+86 13588010568

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026