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MyelofibrosisPhase 2NCT04851535

Study of Jaktinib In Patients With Myelofibrosis Who Were Relapsed or Refractory of Ruxolitinib Treatment.

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 a phase 2, single-arm, open-label, non-randomised, multicentre, study to evaluate the efficacy and safety of Jaktinib in patients with myelofibrosis who were relapsed or refractory of ruxolitinib treatment. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
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
34 participants
Where
1 siteChina
Study dates
28 Jul 2021to 1 Nov 2022
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily sign the informed consent form (ICF);
  • Age ≥ 18 years, either male or female;
  • Subjects diagnosed with a PMF according to World Health Organization (WHO) criteria (2016 Edition), or patients diagnosed with a Post-PV-MF or Post-EF-MF according to International Working Group for Myeloproliferative Neoplasms Research and Treatment (2007 IWG-MRT) criteria;
  • Subjects with intermediate-2 or high-risk myelofibrosis, or Intermediate-1 myelofibrosis with symptoms according to the Dynamic International Prognostic System (DIPSS) scoring system;
  • Subjects are relapsed/refractory to Ruxolitinib:
  • Relapsed defined as Ruxolitinib treatment for ≥ 3 months, following an initial response, regrowth to < 10% spleen volume reduction (SVR) by MRI or < 30% decrease in spleen size by palpation from baseline;
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  • Refractory defined as Ruxolitinib treatment for ≥ 3 months observed inadequate efficacy response: < 10%volume SVR by MRI or < 30% decrease in spleen size by palpation from baseline.
  • Subject has a measurable splenomegaly: spleen volume of ≥ 450 cm3 by MRI/CT and ≥ 5 cm below left costal margin by palpation spleen measuring;
  • Expected life expectancy is greater than 24 weeks;
  • Eastern Cooperative Oncology Group (ECOG) performance Score 0-2;
  • Laboratory examination within 7 days before the randomization, fulfilling the following criteria:
  • Neutrophil count ≥ 0.75 x 109/L, platelet count ≥ 75 x 109/L; Peripheral blood blasts ≤ 10%; ALT and AST≤ 3 ULN, DBIL ≤ 2.0 ULN; Serum creatinine ≤ 2.0 ULN.

Who cannot join

  • Subjects who have been previously exposed to Janus kinase (JAK) inhibitors other than Ruxolitinib for a total of> 2 weeks;
  • Subjects who have taken Ruxolitinib or other JAK inhibitor within 1 week prior to screening;
  • Subjects with any significant clinical and laboratory abnormalities which may affect the safety evaluation, such as uncontrolled diabetes, uncontrolled hypertension after taking two or more hypotensive drugs or peripheral neuropathy;
  • Subjects with congestive heart failure (NCI-CTCAE V5.0) Class II or above, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 6 months prior to screening;
  • Subjects who have a history of chronic or recurrent respiratory diseases, such as: chronic obstructive pulmonary disease, recurrent lung infections, etc., or have a history of lung infections within 3 months before screening, or currently have upper respiratory tract infections that have not recovered;
  • Subjects who have not fully recovered from surgical operation within 4 weeks prior to screening;
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  • Subjects suffering from arrhythmia and requiring treatment, or QTcB > 480ms at screening;
  • Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening;
  • Subjects who had undergone splenectomy, or received radiotherapy to the spleen within 6 months before screening;
  • Subjects with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC);
  • Female subjects who are pregnant, currently breastfeeding, planning to become pregnant;
  • Subjects who had experienced malignant tumors (except for adequately treated local basal cell or squamous cell carcinoma of the skin and cervical carcinoma in situ that have been cured) or in combination with other serious diseases within the past 5 years;
  • Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 month before screening.
  • Subjects who have any other conditions that are not specified in the protocol but the investigator believes that they are not suitable for inclusion in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Phase II Study To Evaluate The Efficacy And Safety of Jaktinib Hydrochloride Tablets In Patients With Myelofibrosis Who Were Relapsed or Refractory of Ruxolitinib Treatment

This was a phase 2, single-arm, open-label, non-randomised, multicentre, study to evaluate the efficacy and safety of Jaktinib in patients with myelofibrosis who were relapsed or refractory of ruxolitinib treatment.

Read the detailed description

All subjects will receive a minimum of 6 treatment cycles or 24 weeks (a 28-day treatment cycle is defined as one treatment cycle).

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 100mg Bid

Study groups in NCT04851535
Study groupRoleWhat they receive
Jaktinib 100mg BidExperimentalJaktinib twice daily for 6 consecutive 28-day cycles, orally, empty stomach
Receives: Drug: Jaktinib Hydrochloride Tablets

What is being measured

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

  1. Spleen Volume Response rate (SVRR) at Week 24

    The proportion of subjects with spleen volume reduction from baseline ≥ 35% measured by MRI or CT.

    Measured: at Week 24

Secondary outcomes (7)

  1. Clinical Objective Response Rate (complete remission (CR) + partial remission (PR))

    International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) response criteria.

    Measured: Baseline, up to Year 2

  2. Spleen Response

    Best response rate: the proportion of subjects with at least one spleen volume reduction ≥ 35% against the baseline; Time to response: the length of time from the date of first dose to the date on which the first spleen volume reduction ≥ 35% against the baseline; Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR): the length of time from the date of the first spleen volume reduction ≥ 35% against the baseline to the date of the spleen volume reduction is less than 35% against the baseline due to spleen volume increase.

    Measured: up to Year 2

  3. Anemia Response

    Proportion of transfusion dependent patients（Transfusion dependent patients：received RBC transfusion ≥ 12 U within 12 weeks before receiving the investigational drug） at baseline turned to non-transfusion dependent patients (non-transfusion dependent patients: no transfusion for at least 12 consecutive weeks and Hgb ≥ 85 g/L); Proportion of hemoglobin (Hgb) elevation ≥ 20 g/L in non-transfusion dependent patients (Hgb ≤ 100 g/L) at baseline; Decline in red blood cell (RBC) transfusion dependence: Number of RBC transfusions decreases by 50%.

    Measured: up to Year 2

  4. Response rate of MF-related symptoms

    Proportion of patients with Myeloproliferative neoplasm symptom assessment form (MPN-SAF) TSS decreasing from baseline by ≥ 50%; The change in MPN-SAF TSS from baseline.

    Measured: Baseline, up to Year 2

  5. Progression free survival (PFS)

    The length of time from the date of first dose to the date of any of the following events: 1) ≥ 25% increase in spleen volume over nadir since the treatment; 2) death from any cause.

    Measured: From the date of first dose to the earliest date of either increase in spleen volume ≥ 25% from on-study nadir or death, up to Year 2

  6. Leukemia free survival (LFS)

    The length of time from the date of first dose to the date of any of the following events: 1) the first bone marrow blast count ≥ 20%; 2) the first peripheral blast count ≥ 20% ; 3) death from any cause.

    Measured: From the date of first dose to the earliest date of either leukemia or death, up to Year 2

  7. Overall survival (OS)

    The length of time from the date of first dose to death from any cause.

    Measured: From the date of first dose to the date of death, up to Year 2

Timeline

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

  1. First posted20 Apr 2021
  2. Study start28 Jul 2021
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04851535
Sponsor's protocol ID
ZGJAK017
Status last verified
Nov 2023
First submitted
8 Apr 2021
Last updated
3 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 12 inclusion and 14 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 3 Nov 2023. 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?

Spleen Volume Response rate (SVRR) at Week 24 (time frame: at Week 24). 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 NCT04851535.

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 3 Nov 2023.

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