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

  • STATUS
    Recruiting
  • End date
    May 10, 2024
  • participants needed
    30
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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Updated on 10 December 2021
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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.

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).

Details
Condition Myelofibrosis, Myelosclerosis with myeloid metaplasia, Post-essential Thrombocythemia Myelofibrosis
Treatment Jaktinib hydrochloride tablets
Clinical Study IdentifierNCT04851535
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on10 December 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects voluntarily sign the informed consent form (ICF)
Age 18 years, either male or female
Subjects diagnosed with a PMF according to World Health Organiztion (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
Refractory defeined 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

Exclusion Criteria

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
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
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