Jaktinib Hydrochloride for the Treatment of Ruxolitinib Intolerance of Myelofibrosis

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Recruiting
participants needed

30
sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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Updated on 19 February 2024

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platelet count

absolute neutrophil count

iron

direct bilirubin

neutrophil count

anemia

myeloproliferative disorder

colony stimulating factor

conjugated bilirubin

ruxolitinib

essential thrombocythemia

myelofibrosis

thrombocytosis

polycythemia

extramedullary hematopoiesis

red blood cell transfusion

hepatosplenomegaly

Summary

This phase IIB, open-label, multicenter study evaluated the efficacy and safety of oral Jaktinib Dihydrochloride in Intermediate-risk and High-risk Myelofibrosis and Previously Treated With Ruxolitinib

Description

Jaktinib Dihydrochloride Monohydrate is a potent inhibitor of JAK1 and JAK2 that demonstrated efficacy and safty in preclinical study and safty in a phase 1 in healthy volunteerThis phase IIB, open-label, multicenter study evaluated the efficacy and safety of oral Jaktinib Dihydrochloride in Intermediate-risk and High-risk Myelofibrosis and Previously Treated With Ruxolitinib

Details

Condition	Myelosclerosis with myeloid metaplasia
Age	18years - 100years
Treatment	Jaktinib hydrochloride tablets
Clinical Study Identifier	NCT04217993
Sponsor	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age greater than or equal to 18 years old ,male or female
	Patients diagnosed with Primary Myelofibrosis according to WHO standard (2016 version), or patients diagnosed with Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis according to International Working Group Myeloproliferative Neoplasms Research and Treatment(IWG-MRT) standard. Both Janus Kinase 2(JAK2)mutation and JAK2 wild can be enrolled
	According to Dynamic International Prognostic Scoring System plus(DIPSS-plus) risk grouping criteria, patients with medium-risk-2 or high-risk myelofibrosis were assessed,Patients with grade 1 medium-risk myelofibrosis with hepatosplenomegaly and no response to existing treatment and requiring treatment can also be enrolled
	Patients who have received or are receiving Ruxolitinib,andRuxolitinib treatment time is not less than 28 days;Red blood cell transfusion is still needed during treatment with Ruxolitinibor Ruxolitinib dose (including starting dose and adjusted dose)20mg bidAnd must meet at least one of the followingLevel 3 or higher platelet count reduction or Level 3 or higher anemia or Level 3 or higher hematoma/bleeding
	a life expectancy > 24 weeks
	Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
	Splenomegaly: palpation of the splenic margin to or above the subcostal at least 5cm
	Within 14 days before enrollmentThe Laboratory indicators meet the following criteria
	Absolute neutrophil countANC > 0.75 x 10^9/Lblood platelet count> 30 x 10^9/L,And no colony stimulating factor was used within 7 days before screening
	Peripheral blood blast < 10%
	ASTALT3xULNPatients with severe extramedullary hematopoiesis or who have received iron therapy within 60 days prior to screening and thus have liver function damage,ASTALT5xULN
	Direct bilirubin2.0ULN
	Creatinine clearance45mL/min
	Meet the requirements of the Ethics Committee, voluntarily sign an informed consent form
	Ability to follow research and follow-up procedures
Exclusion Criteria
	Any significant clinical or laboratory abnormalities that the investigator considers to affect safety assessment, such as: a. uncontrolled diabetes (> 250 mg/dL, or 13.9>mmol/L), b. had high blood pressure and antihypertensive drug treatment under two or unable to descend to the ranges (systolic blood pressure < 160 mmHg, diastolic pressure < 100 mmHg), c. peripheral neuropathy (NCI - CTC AE v5.0 standard grade 2 or above), etc
	The patients who had a history of congestive heart failure(NCI - CTC AE v5.0 standard grade 3or above), uncontrollable or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism in the first 6 months
	Screening of patients who have surgery within the first 4 weeks
	Screening for patients with arrhythmia requiring treatment or QTc interval (QTcB) >480ms
	Screening for bacterial, viral, parasitic or fungal infections that require treatment
	Patients which have with a history of congenital or acquired hemorrhagic diseases;(Note:With the exception of hematoma which caused by Ruxolitinib)
	Splenectomy patients or in the group carried out within three months before the spleen radiation treatment (including internal radiation and external radiation)
	Screening HIV, HBV DNA positive or higher than the normal reference range, or HCV RNA positive for HCV antibody
	Women who are planning to become pregnant or who are pregnant or breast- feeding, as well as those who were unable to use effective contraceptives throughout the trial;Male patients who do not use condoms during the administration and within 2 days (approximately 5 half-lives) after the last administration
	Patients who have suffered from malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the past 5 years; Combined with other serious diseases, the researchers believe that patients' safety or compliance may be affected
	With other serious diseases, the researchers think that may affect patient safety or compliance
	The patients who had used the Jakatinib hydrochloride
	Patients who have participated in the clinical trials of other new drugs or medical devices within the first 1 months
	The patients who used the Hematopoietic growth factors within 14 days before Into the group (granulocyte growth factors, or platelet hormone)
	Patients who cannot cooperate with or cannot perform MRI or CT scans
	Patients with refractory or recurrent myelofibrosis
	refractory of myelofibrosis:After at least 28 days of adequate administration
	of JAK inhibitors, the spleen palpation was less than 15% smaller than before
	administration.Or at least 3 months later, the spleen volume on MRI/CT
	decreased by <10% compared with that before the administration
	Recurrence of myelofibrosis: after at least 3 months of taking adequate amount
	of JAK inhibitor, the spleen was enlarged again after shrinking compared with
	that before taking the drug, and compared with the minimum value during taking
	the drug, the spleen volume increased 10% on MRI/CT examination or 30% on
	spleen palpation
	\. Any treatment MF medication (eg hydroxyurea,except ruxolitinib ), any
	immunomodulation used within 2 weeks prior to enrollment Agent (such as
	thalidomide), any immunosuppressant, glucocorticoids 10 mg/day of prednisone
	or equivalent biological strength, or patients within 6 half-life of the drug
	over time Prevail;Patients who had received rucotinib within 1 week prior to
	enrolling

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platelet count

absolute neutrophil count

myeloproliferative disorder

colony stimulating factor

conjugated bilirubin

ruxolitinib

essential thrombocythemia

myelofibrosis

thrombocytosis

polycythemia

extramedullary hematopoiesis

red blood cell transfusion

hepatosplenomegaly

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Study Definition

Wikipedia

Jaktinib Hydrochloride for the Treatment of Ruxolitinib Intolerance of Myelofibrosis