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RECRUITING
NCT07317700
PHASE3

A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis

Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

View on ClinicalTrials.gov

Summary

This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria. Continuously take the test drug/control drug until it meets the withdrawal criteria.

Official title: A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2026-02-13

Completion Date

2028-03-30

Last Updated

2026-03-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Flonoltinib 75mg

Flonoltinib 75mg,qd

DRUG

Ruxolitinib Phosphate

Ruxolitinib Phosphate ,control group

Locations (2)

West China Hospital Sichuan University

Chengdu, Sichuan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

Tianjin, Tianjin Municipality, China