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MyelofibrosisPhase 2NCT03886415

Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis.

A Phase 2 study testing Jaktinib hydrochloride tablets in people with Myelofibrosis, 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 was an open-label, multi-center, randomized phase 2 study. This is a two-stage design.In the first stage, two dose groups were set up, the 100 mg bid dose group and the 200 mg qd dose group, which were randomized at 1:1, with 50 subjects in each group, and a total of 100 cases in the two groups. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelofibrosis
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
118 participants
Where
1 siteChina
Study dates
8 Jan 2019to 2 Feb 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1、18 years age or older ,male or female;
  • 2、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；
  • 3、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;
  • 4、Subjects did not have a recent stem cell transplant program;
  • 5、a life expectancy > 24 weeks;
  • 6、Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2；
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  • 7、Splenomegaly: palpation of the splenic margin to or above the subcostal at least 5 cm；
  • 8、Peripheral blood protocells ≤10%；
  • 9、Patients who have not previously been treated with JAK inhibitors；
  • 10、Absolute neutrophil count（ANC） ≥1000/uL, platelet count ≥75 × 109/L without growth factor, platelet production factor or platelet infusion.Subjects did not receive growth factor infusion within 2 weeks before randomization;
  • 11、Seven days before randomization, the main organs were functioning normally, which met the following criteria： alanine transaminase（ALT）and aspartate aminotransferase（AST）≤2.5×upper limit of normal (ULN)； direct bilirubin（DBIL）and total bilirubin (TBIL)≤1.5×upper limit of normal (ULN）；serum creatinine ≤2.5×upper limit of normal (ULN)，calculated creatinine clearance（CrCl）≥50mL/min；
  • 12、 Voluntarily sign informed consent in accordance with the requirements of the ethics committee;
  • 13、Ability to follow study 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 v4.03 standard grade 2 or above), d. thyroid dysfunction (> NCI - CTC AE v4.03 standard grade 2 or above);
  • The patients had a history of congestive heart failure, uncontrollable or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism in the first 6 months;
  • Screening of patients who have not fully recovered from 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 with any clinical symptoms that require treatment;
  • Patients with a history of congenital or acquired hemorrhagic diseases;
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  • Patients who had previously undergone splenectomy or who had received radiotherapy of the splenic region within the first 12 months of screening;
  • Screening for HIV positive, active hepatitis b virus positive (HBsAg positive, hbv- dna positive or greater than 1000 copies /ml), anti-hcv antibody or hcv-rna positive;
  • Patients suffering from epilepsy or using psychotropic or sedative drugs at the time of screening;
  • 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;
  • Suspected allergic to Jakatinib hydrochloride or similar drugs;
  • Patients who have participated in the clinical trials of other new drugs or medical devices within the first 3 months;
  • Patients who were treated with any MF drug (e.g., hydroxyl urea), any immunomulator (e.g., thalidomide), any immunosuppressant, prednisone at or above 10mg/ day or equivalent bioactive level of glucocorticoid, growth factor (e.g.,erythropoietin ), or who were within 6 half-lives of the drug within 2 weeks prior to randomization;

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: A Phase 2,Multi-center, Open-label Study Evaluating Safety and Efficacy of Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis.

This was an open-label, multi-center, randomized phase 2 study. This is a two-stage design.In the first stage, two dose groups were set up, the 100 mg bid dose group and the 200 mg qd dose group, which were randomized at 1:1, with 50 subjects in each group, and a total of 100 cases in the two groups. In the second stage, approximately 36 subjects were added to the randomized group.

Read the detailed description

According to the results of the interim analysis of the ZGJAK002 of Jaktinib, a comprehensive evaluation of the benefits and risks of subjects in the 100mg bid and 200mg qd groups, the investigator and the sponsor decided to expand the enrollment of approximately 36 subjects taking 100mg bid.

Conditions
Myelofibrosis
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

    Jaktinib hydrochloride tablets 100mg bid dose group and Jaktinib hydrochloride tablets 200mg qd dose group

Study groups in NCT03886415
Study groupRoleWhat they receive
Jaktinib hydrochloride tablets 1ExperimentalThis is the dose group was given once a day. Jaktinib hydrochloride tablets 1 200mg qd dose group
Receives: Drug: Jaktinib hydrochloride tablets
Jaktinib hydrochloride tablets 2ExperimentalThis is the dose group was given twice a day. Jaktinib hydrochloride tablets 2 100mg bid dose group
Receives: Drug: Jaktinib hydrochloride tablets

What is being measured

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

  1. effective rate

    The proportion of all subjects whose spleen volume decreased by 35% or more at 24 weeks

    Measured: 24 weeks

Secondary outcomes (7)

  1. Overall response rate （CR+PR）

    IWG-MRT efficacy criteria

    Measured: 24 weeks

  2. The spleen response

    The time from baseline to the first splenic volume reduction was greater than or equal to 35%；Optimal response: the proportion of patients whose spleen volume decreased by more than 35% compared with the baseline at least once;Effective time: the time from the randomization date to the first time the spleen volume decreased by more than 35% from the baseline；DoMSR: the time between the first occurrence of spleen volume reduction of more than 35% from the baseline to the increase of spleen volume less than 35% from the baseline;

    Measured: 24 weeks

  3. Anemia response

    Baseline proportion of patients with blood transfusion dependence converted to patients without blood transfusion dependence（Patients without blood transfusion dependence: patients without red blood cell transfusion for more than 12 weeks during the treatment period and with HGB ≥85g/L）;The proportion of patients with baseline non-transfusion dependence (HGB ≤100g/L) whose HGB increased by 20g/L;RBC Infusion dependence decreased: RBC infusion frequency decreased by 50%;

    Measured: 24 weeks

  4. MF related symptom response rate

    MPN-SAF TSS the proportion of patients whose total symptom score of the scale decreased by more than 50%;MPN-SAF TSS the total scale symptom score was lower than baseline

    Measured: 24 weeks

  5. Progression-free survival (PFS)

    PFS was defined as the time from date of randomization to disease progression radiological or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of disease evaluation.

    Measured: 24 weeks

  6. Leukemia-free survival（LFS）

    The time elapsed between the dates of any of the following events from a randomized solstice；The first bone marrow smear showed that the original cells were more than 20% of the date；The initial peripheral blood smear showed that the original cells were more than 20% and A peripheral blood blast content of 20% associated with an absolute blast count of 1*10(9)/L that lasts for at least 2 weeks；Death from any cause. Subjects without anyone of events at the time of analysis were censored at their last date of disease evaluation.

    Measured: 24 weeks

  7. Overall survival (OS)

    OS is defined as the time from date of randomization to death due to any cause. Subjects without death at the time of analysis were censored at their last date of follow-up.

    Measured: 2 years

Timeline

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

  1. First posted22 Mar 2019
  2. Study start8 Jan 2019
  3. Primary completion2 Feb 2021
  4. Study completion2 Feb 2021

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03886415
Sponsor's protocol ID
ZGJAK002
Status last verified
Nov 2022
First submitted
20 Mar 2019
Last updated
29 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share date of the trial

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Jaktinib hydrochloride tablets in people with Myelofibrosis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effective rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03886415.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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