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MyelofibrosisPhase 3NCT04617028

Jaktinib Versus Hydroxycarbamide in Subjects With Intermediate-2 or High-risk Myelofibrosis

A Phase 3 study testing Jaktinib and Hydroxycarbamide 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 study is to determine the efficacy of Jaktinib versus Hydroxycarbamid in participants with Intermediate-2 or High-risk myelofibrosis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myelofibrosis
What is being tested?
Jaktinib and Hydroxycarbamide Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
1 siteChina
Study dates
5 Feb 2021to 18 Oct 2023
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old,either male or female;
  • Subjects diagnosed with a PMF according to World Health Organiztion 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 criteria;
  • High risk or intermediate-2 risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for Primary Myelofibrosis;
  • Subjects have no plan for stem cell transplantation in the near future;
  • Life expectancy of > 24 weeks;
  • ECOG performance status of 0-1;
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  • Palpable splenomegaly at least 5 cm below left costal margin;
  • Peripheral blood blast count ≤ 10%;
  • Subjects who have not yet received treatment with a JAK inhibitor, or Subjects who have been treated with JAK inhibitors for ≤10 days;
  • Subjects have not received growth factor, thrombopoietin mimetics or platelet transfusion(s) within 2 weeks before the randomization; ANC≥ 1.0×10^9/L, platelet count ≥ 100×10^9/L within 2 days before the randomization;
  • Normal functions in major organs within 7 days before the randomization, fulfilling the following criteria: ALT and AST ≤ 2.5×ULN; DBIL and TBIL ≤ 2.0×ULN; serum creatinine ≤ 1.5×ULN;
  • If the subject is receiving any anti-myelofibrosis treatment (except for JAK inhibitors and hydroxyurea) at screening, the dosing regimen must remain unchanged for at least 2 weeks before screening. If the investigator judges that there is no need to continue to use, stop the use of thalidomide, androgens and prednisone> 10 mg during screening. The drugs used to improve anemia should be stopped for at least 6 half-lives or 2 weeks before randomization(whichever is the longer);
  • If the subject is receiving Hydroxycarbamide treatment at screening, the drug must be discontinued ≥ 2 weeks before the randomization;
  • Meet the requirements of the ethics committee and willing to sign the informed consent form;
  • Ability to comply with trial and follow-up procedures.

Who cannot join

  • 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, peripheral neuropathy;
  • Subjects with congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening;
  • Subjects who have not fully recovered from surgical operation within 4 weeks prior to screening;
  • Subjects suffering from arrhythmia and requiring treatment at screening;
  • Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening;
  • Chest X-rays suggest an active lung infection at screening;
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  • Subjects who had active tuberculosis infection within 48 weeks before screening;γ-Interferon release test suggests latent tuberculosis infection at screening;
  • Subjects who had undergone splenectomy, or received radiotherapy to the spleen within 48 weeks before screening;
  • Subjects with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC);
  • Subjects with epilepsy or patients who have received psychotropic drug or sedatives during screening;
  • Female subjects who are pregnant, currently breastfeeding, planning to become pregnant;Subjects who are unable to adopt effective contraceptive methods during the study; Male subjects who did not use condoms during the dosing period and within 2 days after the last dose
  • Subjects who had experienced malignant tumors within the past 5 years (except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ that have been cured);
  • Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator;
  • Subjects with suspected allergies to Jaktinib or its excipient;
  • Subjects who have participated in another clinical trial of a new drug or medical instrument within 12 weeks before screening.

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 Randomized, Double-blind, Double-simulated, Parallel-controlled, Multicenter Phase III Study Evaluating the Efficacy and Safety of Jaktinib Versus Hydroxycarbamide in Patients With Intermediate-2 or High-risk Myelofibrosis

This study is to determine the efficacy of Jaktinib versus Hydroxycarbamid in participants with Intermediate-2 or High-risk myelofibrosis

Conditions
Myelofibrosis
Being tested
Jaktinib, Placebo to match Hydroxycarbamide, Hydroxycarbamide Tablets, Placebo to match Jaktinib
Medical subject headings
Primary Myelofibrosis

What participants receive

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

  • JaktinibDrug

    Jaktinib Hydrochloride Tablets administered orally twice daily

  • Placebo to match HydroxycarbamideDrug

    Placebo to match Hydroxycarbamide Tablets administered orally twice daily

  • Hydroxycarbamide TabletsDrug

    Hydroxycarbamide Tablets administered orally twice daily

  • Placebo to match JaktinibDrug

    Placebo to match Jaktinib Tablets administered orally twice daily

Study groups in NCT04617028
Study groupRoleWhat they receive
JaktinibExperimentalParticipants will receive Jaktinib plus placebo to match Hydroxycarbamide.
Receives: Drug: Jaktinib; Drug: Placebo to match Hydroxycarbamide
HydroxycarbamideActive comparatorParticipants will receive Hydroxycarbamide plus placebo to match Jaktinib.
Receives: Drug: Hydroxycarbamide Tablets; Drug: Placebo to match Jaktinib

What is being measured

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

  1. 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 as measured by MRI or CT

    Measured: Week 24

Secondary outcomes (1)

  1. Proportion of transfusion dependent patients converted to non-transfusion dependent patients at baseline

    Measured: From start of drug administration up to 7 days after last dose of study treatment

Timeline

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

  1. First posted5 Nov 2020
  2. Study start5 Feb 2021
  3. Primary completion18 Oct 2023
  4. Study completion18 Oct 2023

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617028
Sponsor's protocol ID
ZGJAK016
Status last verified
Nov 2023
First submitted
26 Oct 2020
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Y, Zhou H, Suo S, Zhuang J, Yang L, He A, Liu Q, Du X, Gao S, Li Y, Li Y, Chen Y, Wu W, Zhu H, He G, Hong M, Jiang Q, Jiang Z, Jing H, Wang J, Xu N, Yue L, Zheng C, Zhou Z, Jin C, Li X, Liu L, Xu Y, Wu D, Zhang F, Zhang J, Wu L, Yin H, Lv B, Xiao Z, Jin J. Evaluation of gecacitinib vs hydroxyurea in patients with intermediate-2 or high-risk myelofibrosis: final analysis results from a randomized phase 3 study. Blood Cancer J. 2024 Dec 18;14(1):216. doi: 10.1038/s41408-024-01202-8.

    PubMed 39695117

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Jaktinib and Hydroxycarbamide 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 15 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 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Splenic response rate at Week 24 (time frame: 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 NCT04617028, which also lists 1 linked publication.

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 13 Nov 2023.

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