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

Suzhou Zelgen Biopharmaceuticals Co.,Ltd1 site in 1 country34 target enrollmentJuly 28, 2021

ConditionsMyelofibrosis

InterventionsJaktinib Hydrochloride Tablets

DrugsJaktinib Hydrochloride Tablets

Overview

Phase: Phase 2
Intervention: Jaktinib Hydrochloride Tablets
Conditions: Myelofibrosis
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Enrollment: 34
Locations: 1
Primary Endpoint: Spleen Volume Response rate (SVRR) at Week 24
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

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).

Registry

clinicaltrials.gov

Start Date

July 28, 2021

End Date

November 1, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Responsible Party

Sponsor

Eligibility Criteria

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 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;
•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;

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);

Arms & Interventions

Jaktinib 100mg Bid

Jaktinib twice daily for 6 consecutive 28-day cycles, orally, empty stomach

Intervention: Jaktinib Hydrochloride Tablets

Outcomes

Primary Outcomes

Spleen Volume Response rate (SVRR) at Week 24

Time Frame: at Week 24

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

Secondary Outcomes

Clinical Objective Response Rate (complete remission (CR) + partial remission (PR))(Baseline, up to Year 2)
Spleen Response(up to Year 2)
Anemia Response(up to Year 2)
Response rate of MF-related symptoms(Baseline, up to Year 2)
Progression free survival (PFS)(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)
Leukemia free survival (LFS)(From the date of first dose to the earliest date of either leukemia or death, up to Year 2)
Overall survival (OS)(From the date of first dose to the date of death, up to Year 2)