Essential Thrombocythemia
Conditions
Interventions
Experimental Group:Ropeginterferon alfa-2b Injection
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Ability to understand and voluntarily sign the Informed Consent Form (ICF), and willingness and ability to complete the protocol-required scheduled visits, treatment plan, laboratory tests, and other trial procedures. 2.Male or female patients aged >18 years at the time of signing the ICF. 3.Diagnosed with ET according to the 2016 WHO diagnostic criteria for myeloproliferative neoplasms, aged 3.5 g/dL, alanine aminotransferase (ALT) 450 × 10^9/L (450 k/µL) and absolute neutrophil count (ANC) >=0.75 × 10^9/L assessed within 72 hours prior to study drug administration. 8.Creatinine clearance >=40 mL/min at screening (calculated using the Cockcroft-Gault formula). 9.Men and women of childbearing potential, and all women with menopause duration less than 2 years, must agree to use an acceptable method of contraception from screening until 28 days after the last dose of study drug. 10.Patient life expectancy >5 years as assessed by the investigator.
Exclusion criteria
Exclusion criteria: 1.Patients with symptomatic splenomegaly. 2.Any contraindication to interferon alfa or hypersensitivity to interferon alfa; 3.Presence of severe or serious concomitant diseases that, in the investigator’s opinion, may affect the patient’s participation in this study. 4.History of vital organ transplantation; 5.Female patients who are pregnant or breastfeeding; 6.Patients with any other diseases that, in the investigator’s judgment, may affect the study results or compromise protocol compliance. 7.Poorly controlled diabetes mellitus (HbA1c > 8%); 8.Active thromboembolic complications and intra-abdominal bleeding; 9.History of any malignancy within the past 5 years (except adequately treated non-melanoma skin cancer, post-resection prostate cancer with undetectable prostate-specific antigen [PSA], radically treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast [DCIS], stage 1 grade 1 endometrial cancer, or other solid tumors including lymphoma with no evidence of disease for >=2 years prior to study entry after radical treatment [without bone marrow involvement]). 10.History of alcohol or drug abuse within the past 1 year; 11.History of or evidence of current post-polycythemia vera myelofibrosis (PPV-MF), essential thrombocythemia, or any myeloproliferative neoplasm (MPN) other than polycythemia vera (PV). 12.Presence of blasts in peripheral blood within the past 3 months; 13.Use of any investigational product or combination investigational product within 4 weeks prior to the first dose of study drug, or failure to recover from effects caused by any prior investigational product. 14.Female patients who are breastfeeding or pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Values of CALR, JAK2, and MPL;To evaluate the molecular remission rate of ET patients treated with ropeinterferon for 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| The complete hematological response (CR) rate at 12 months of treatment was evaluated based on the ELN2013 criteria;JAK2, CALR, MPL gene burden was evaluated with time after 6 and 12 months of treatment the;Other nondriver mutations were changed from time to treatment;Changes in clinical symptom burden of MPN-SAF TSS in patients;Incidence of thromboembolic events;Progression-free survival (PFS) and event-free survival (EFS) were evaluated.;The proportion of patients with improvement or no progression in spleen size was evaluated;Quality of life (EQ-5D-3L) was assessed;The patient's bone marrow biopsy changes;The possibility of drug withdrawal was explored; | — |
Countries
China
Contacts
Public ContactHuang Jian
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed