Neoplasms

Blood and Lymph Conditions

All Conditions

Heart and Blood Diseases

Rare Diseases

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Myeloproliferative Disorders

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Essential Thrombocythemia

Chronic Myeloproliferative Disorders

This is the dose group was given Jaktinib Hydrochloride Tablets 100mg （2 tablets）dose group for twice a day.

This is the dose group was given Jaktinib Hydrochloride Tablets 150mg （3 tablets）dose group for once a day.

This is the dose group was given Jaktinib Hydrochloride Tablets 100mg （2 tablets） dose group for once a day

This is the dose group was given Jaktinib Hydrochloride Tablets 200mg （4 tablets）dose group for once a day.

Jaktinib hydrochloride tablets 100mg twice dose group，Jaktinib hydrochloride tablets 150mg qd dose group, Jaktinib hydrochloride tablets 200mg qd dose group and Jaktinib hydrochloride tablets 100mg qd dose group

Jaktinib hydrochloride tablets

Jie Jin, MD

This phase IIB, open-label, multicenter study evaluated the efficacy and safety of oral Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis and Previously Treated With Ruxolitinib. The experiment is divided into two parts: dose exploration and extended research.

dose exploration: It is planned to enroll about 6 subjects. According to the baseline value of platelet count at the time of enrollment, different doses (100mg Qd or 150mg Qd or 200mg Qd or 100mg Bid) of Jaktinib Hydrochloride Tablets will be Treated. The trial is in progress Adjust the dose according to relevant laboratory indicators. When at least one subject has a spleen volume reduction of ≥35% from the baseline, the sponsor and the investigator will jointly decide whether to enter the extended study part.

Extended research: It is planned to enroll about 43 subjects, and the initial dosage of Jaktinib Hydrochloride Tablets is planned to be 100mg Bid.

Jaktinib for the Treatment of Ruxolitinib Intolerance of Myelofibrosis

Jaktinib in Intermediate-risk and High-risk Myelofibrosis and Previously Treated With Ruxolitinib

Splenic response rate at Week 24 is defined as the proportion of participants achieving a ≥ 35% reduction in spleen volume at Week 24 from baseline

Proportion of anemia response in all of anemia patients

TSS response is defined as the proportion of subjects who achieve a ≥ 50% reduction in TSS at the Week 24 compared to baseline

The time from the date of enrollment to the date on which any of the following events occurred：①Spleen volume increased by ≥25% compared to the lowest value recorded during the trial including baseline；②Death from any cause

The time elapsed from the date of enrollment to the date of any of the following events：①The first bone marrow smear shows the date of ≥20% of the original cells；②The first peripheral blood smear showed ≥20% of the original cells and the absolute value of the original cells was ≥1×10\^9/L for at least 2 weeks；③Death from any cause。

Time elapsed from the date of enrollment to death from any cause

Vital signs, physical examination, blood routine; severity and incidence of adverse events and adverse reactions (NCI-CTCAE V4.03)

Arterial thrombosis：①Coronary heart disease；②Cerebral arterial thrombosis；③Peripheral arterial occlusive disease：Such as mesenteric artery thrombosis and extremity arterial thrombosis。Venous thrombosis：①Thrombophlebitis；②Deep vein thrombosis；③Pulmonary embolism。Microcirculatory thrombosis: ① thrombotic thrombocytopenic purpura; ② hemolytic uremic syndrome; ③ extracorporeal circulation thrombosis; ④other: such as fulminant purple epilepsy and disseminated intravascular coagulation

Spots Global Cancer Trial Database for jaktinib hydrochloride tablets