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

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04617028
Collaborator
(none)
105
1
2
33.8
3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Jaktinib
  • Drug: Placebo to match Hydroxycarbamide
  • Drug: Hydroxycarbamide Tablets
  • Drug: Placebo to match Jaktinib
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 5, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Jaktinib

Participants will receive Jaktinib plus placebo to match Hydroxycarbamide.

Drug: Jaktinib
Jaktinib Hydrochloride Tablets administered orally twice daily

Drug: Placebo to match Hydroxycarbamide
Placebo to match Hydroxycarbamide Tablets administered orally twice daily

Active Comparator: Hydroxycarbamide

Participants will receive Hydroxycarbamide plus placebo to match Jaktinib.

Drug: Hydroxycarbamide Tablets
Hydroxycarbamide Tablets administered orally twice daily

Drug: Placebo to match Jaktinib
Placebo to match Jaktinib Tablets administered orally twice daily

Outcome Measures

Primary Outcome Measures

  1. Splenic response rate at Week 24 [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

Secondary Outcome Measures

  1. Proportion of transfusion dependent patients converted to non-transfusion dependent patients at baseline [From start of drug administration up to 7 days after last dose of study treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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≥ 1.0×109/L, platelet count ≥ 100×109/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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Medical School of Zhejiang University Hangzhou Zhejiang China 310003

Sponsors and Collaborators

  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

  • Study Chair: Jie Jin, PhD, The First Affiliated Hospital of Medical School of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT04617028
Other Study ID Numbers:
  • ZGJAK016
First Posted:
Nov 5, 2020
Last Update Posted:
Jun 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2021