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

NCT ID: NCT04617028

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2023-10-18

Brief Summary

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

Conditions

Myelofibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Jaktinib

Participants will receive Jaktinib plus placebo to match Hydroxycarbamide.

Group Type: EXPERIMENTAL

Jaktinib

Intervention Type: DRUG

Jaktinib Hydrochloride Tablets administered orally twice daily

Placebo to match Hydroxycarbamide

Intervention Type: DRUG

Placebo to match Hydroxycarbamide Tablets administered orally twice daily

Hydroxycarbamide

Participants will receive Hydroxycarbamide plus placebo to match Jaktinib.

Group Type: ACTIVE_COMPARATOR

Hydroxycarbamide Tablets

Intervention Type: DRUG

Hydroxycarbamide Tablets administered orally twice daily

Placebo to match Jaktinib

Intervention Type: DRUG

Placebo to match Jaktinib Tablets administered orally twice daily

Interventions

Jaktinib

Jaktinib Hydrochloride Tablets administered orally twice daily

Intervention Type: DRUG

Placebo to match Hydroxycarbamide

Placebo to match Hydroxycarbamide Tablets administered orally twice daily

Intervention Type: DRUG

Hydroxycarbamide Tablets

Hydroxycarbamide Tablets administered orally twice daily

Intervention Type: DRUG

Placebo to match Jaktinib

Placebo to match Jaktinib Tablets administered orally twice daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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;
• 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jie Jin, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Medical School of Zhejiang University

Locations

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39695117 (View on PubMed)

Other Identifiers

ZGJAK016

Identifier Type: -

Identifier Source: org_study_id