Primary Myelofibrosis (PMF)Phase 2NCT04217993

Jaktinib for the Treatment of Ruxolitinib Intolerance of Myelofibrosis

A Phase 2 study testing Jaktinib hydrochloride tablets in people with Primary Myelofibrosis (PMF) and Post-polycythemia Vera Myelofibrosis(Post-PV MF), run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis(Post-PV MF), Post-essential Thrombocythemia Myelofibrosis(Post-ET MF)
What is being tested?: Jaktinib hydrochloride tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteChina
Study dates: 7 Jan 2020to 3 Aug 2022
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-75 years old (including the threshold value), gender is not limited;
Subjects diagnosed with Primary Myelofibrosis according to World Health Organization (WHO) criteria (2016 version), or 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(DIPSS) , Subjects with intermediate-risk-2 or high-risk myelofibrosis were assessed, Subjects with intermediate-risk-1 myelofibrosis with hepatosplenomegaly and no response to existing treatment and requiring treatment can also be enrolled;
Subjects who have received or are receiving Ruxolitinib, and：Ruxolitinib treatment time is not less than 28 days; Red blood cell transfusion is still needed during treatment with Ruxolitinib; or Ruxolitinib dose (including starting dose and adjusted dose)<20mg bid，And must meet at least one of the following：Level 3 or higher platelet count reduction or Level 3 or higher anemia or Level 3 or higher hematoma/bleeding；
Life expectancy > 24 weeks;
Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2；

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Splenomegaly: palpation of the splenic margin to or above the subcostal at least 5cm；
Acceptable laboratory assessments obtained within 14 days prior to enrollment:
Absolute neutrophil count(ANC)>0.75 x 10^9/L, blood platelet count>100 x 10^9/L;
Peripheral blood blast count < 10%;
Aspartate transaminase (AST) and alanine transaminase (ALT)≤3 x the upper limit of the normal range (ULN); Subjects with liver function impairment due to severe extramedullary haematopoiesis or iron removal therapy within 60 days prior to screening, AST and ALT≤5 x ULN; Direct bilirubin≤2.0 x ULN;
Calculated creatinine clearance of≥45 mL/min；
Meet the requirements of the Ethics Committee, voluntarily sign an informed consent form；
Ability to follow research and follow-up procedures.

Who cannot join

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 grade 2 or above), etc;
Subjects who had a history of congestive heart failure(NCI-CTC AE v5.0 grade 3 or above), uncontrollable or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism in the first 6 months;
Screening of Subjects who have surgery within the first 4 weeks;
Screening for Subjects 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)

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Splenectomy Subjects 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;
Subjects 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;
Subjects who had used the Jaktinib;
Subjects who have participated in the clinical trials of other new drugs or medical devices within the first 1 months;
Subjects who used the Hematopoietic growth factors within 14 days before Into the group (granulocyte growth factors, or platelet hormone) ；
Subjects who cannot cooperate with or cannot perform MRI or CT scans；
Subjects 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 Subjects within 6 half-life of the drug, over time Prevail; Subjects who had received Ruxolitinib within 1 week prior to enrolling.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, 310003

Other trials in China

About this study

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

Read the detailed description

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.

Conditions: Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis(Post-PV MF), Post-essential Thrombocythemia Myelofibrosis(Post-ET MF)
Being tested: Jaktinib hydrochloride tablets
Medical subject headings: Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Jaktinib hydrochloride tabletsDrug
Also called Jaktinib
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

Study groups in NCT04217993
Study group	Role	What they receive
Jaktinib Hydrochloride Tablets 100mg twice a day.	Experimental	This is the dose group was given Jaktinib Hydrochloride Tablets 100mg （2 tablets）dose group for twice a day. Receives: Drug: Jaktinib hydrochloride tablets
Jaktinib Hydrochloride Tablets 150mg once a day	Experimental	This is the dose group was given Jaktinib Hydrochloride Tablets 150mg （3 tablets）dose group for once a day. Receives: Drug: Jaktinib hydrochloride tablets
Jaktinib Hydrochloride Tablets 100mg once a day	Experimental	This is the dose group was given Jaktinib Hydrochloride Tablets 100mg （2 tablets） dose group for once a day Receives: Drug: Jaktinib hydrochloride tablets
Jaktinib Hydrochloride Tablets 200mg once a day	Experimental	This is the dose group was given Jaktinib Hydrochloride Tablets 200mg （4 tablets）dose group for once a day. Receives: Drug: Jaktinib hydrochloride tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Splenic response rate at Week 24
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
Measured: week 24

Secondary outcomes (8)

Objective response rate
IWG-MRT efficacy criteria
Measured: up to 24 weeks
Anemia response rate
Proportion of anemia response in all of anemia patients
Measured: up to 24 weeks
Total symptoms score(TSS) response rate
TSS response is defined as the proportion of subjects who achieve a ≥ 50% reduction in TSS at the Week 24 compared to baseline
Measured: up to 24 weeks
Progression-free survival
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
Measured: up to 24 weeks
Leukemia-free survival
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。
Measured: up to 2 years
Overall survival
Time elapsed from the date of enrollment to death from any cause
Measured: up to 2 years
Adverse event rate
Vital signs, physical examination, blood routine; severity and incidence of adverse events and adverse reactions (NCI-CTCAE V4.03)
Measured: up to 28 weeks
Thrombotic event rate
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
Measured: up to 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 20203 Aug 2022

First posted6 Jan 2020
Study start7 Jan 2020
Primary completion3 Aug 2022
Study completion3 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Myelofibrosis (PMF)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04217993
Sponsor's protocol ID: ZGJAK006
Status last verified: Apr 2023
First submitted: 10 Nov 2019
Last updated: 20 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan to share date of the trial

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
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Polycythemia Vera (PV), Myelofibrosis (MF)
Active, not recruitingPhase 1
Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF)
Active, not recruitingPhase 2
Extended Access of Momelotinib in Adults With Myelofibrosis
Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF)

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