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.
All subjects will receive a minimum of 6 treatment cycles or 24 weeks (a 28-day treatment cycle is defined as one treatment cycle).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Jaktinib 100mg Bid
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Spleen Volume Response rate (SVRR) at Week 24
The proportion of subjects with spleen volume reduction from baseline ≥ 35% measured by MRI or CT.
Time frame: at Week 24
Clinical Objective Response Rate (complete remission (CR) + partial remission (PR))
International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) response criteria.
Time frame: Baseline, up to Year 2
Spleen Response
Best response rate: the proportion of subjects with at least one spleen volume reduction ≥ 35% against the baseline; Time to response: the length of time from the date of first dose to the date on which the first spleen volume reduction ≥ 35% against the baseline; Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR): the length of time from the date of the first spleen volume reduction ≥ 35% against the baseline to the date of the spleen volume reduction is less than 35% against the baseline due to spleen volume increase.
Time frame: up to Year 2
Anemia Response
Proportion of transfusion dependent patients（Transfusion dependent patients：received RBC transfusion ≥ 12 U within 12 weeks before receiving the investigational drug） at baseline turned to non-transfusion dependent patients (non-transfusion dependent patients: no transfusion for at least 12 consecutive weeks and Hgb ≥ 85 g/L); Proportion of hemoglobin (Hgb) elevation ≥ 20 g/L in non-transfusion dependent patients (Hgb ≤ 100 g/L) at baseline; Decline in red blood cell (RBC) transfusion dependence: Number of RBC transfusions decreases by 50%.
Time frame: up to Year 2
Response rate of MF-related symptoms
Proportion of patients with Myeloproliferative neoplasm symptom assessment form (MPN-SAF) TSS decreasing from baseline by ≥ 50%; The change in MPN-SAF TSS from baseline.
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Time frame: Baseline, up to Year 2
Progression free survival (PFS)
The length of time from the date of first dose to the date of any of the following events: 1) ≥ 25% increase in spleen volume over nadir since the treatment; 2) death from any cause.
Time frame: 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)
The length of time from the date of first dose to the date of any of the following events: 1) the first bone marrow blast count ≥ 20%; 2) the first peripheral blast count ≥ 20% ; 3) death from any cause.
Time frame: From the date of first dose to the earliest date of either leukemia or death, up to Year 2
Overall survival (OS)
The length of time from the date of first dose to death from any cause.
Time frame: From the date of first dose to the date of death, up to Year 2