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This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants. Eligible participants will be stratified and assigned in a 1:1:1 ratio to the low-dose flonoltinib maleate tablet group, high-dose flonoltinib maleate tablet group, or the ruxolitinib tablet group. Stratification factor include the Dynamic International Prognostic Scoring System (DIPSS) risk classification (intermediate-2 and high risk)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose group | Experimental | Flonoltinib 50mg |
|
| high dose group | Experimental | Flonoltinib 100mg |
|
| control group | Active Comparator | Ruxolitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flonoltinib 50mg | Drug | Flonoltinib 50mg, QD |
| |
| Flonoltinib 100mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC) | Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC) | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researcher) | Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by researcher) | Week 24 |
| Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researcher) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liangkun Sun | Contact | 15885742617 | liangkunsun@zenitar.cn | |
| Zheng Jiang | Contact | 19048075294 | zhengjiang@zenitar.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhijian Xiao, Doctor | Hematology Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Ting Niu, Doctor | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41883618 | Derived | Yang L, Tan K, Liang R, Zhang W, Wang Y, Chen L. Assessment of flonoltinib maleate versus ruxolitinib phosphate in intermediate- to high-risk myelofibrosis (FMF-02): study protocol for a multicenter, randomized, open-label phase IIB trial. Ther Adv Hematol. 2026 Mar 19;17:20406207261424845. doi: 10.1177/20406207261424845. eCollection 2026. |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| Drug |
Flonoltinib 100mg, QD |
|
| Ruxolitinib | Drug | For patients with platelet counts between 100×10^9/L and 200×10^9/L, the recommended starting dose is 15 mg twice daily (bid). For patients with platelet counts >200×10^9/L, the recommended starting dose is 20 mg bid. For patients with platelet counts between 50×10^9/L and <100×10^9/L, the recommended maximum starting dose is 5 mg bid. |
|
Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researcher) |
| Week 12 |
| Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by IRC) | Percentage of subjects with ≥35% reduction in spleen volume from baseline( Evaluation by IRC) | Week 12 |
| Percentage of subjects with ≥50% reduction in MPN-SAF TSS scale total symptom score | Percentage of subjects with ≥50% reduction in MPN-SAF TSS scale total symptom score | Week 24 and Week 12 |
| Objective response rate (ORR = CR + PR) per the IWG-MRT consensus criteria. | Objective response rate (ORR = CR + PR) per the IWG-MRT consensus criteria. | Week 24 |
| Hematology Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
|