Polycythemia vera (PV) and essential thrombocythemia (ET)
Conditions
Interventions
PEG-IFN a-2b group:None
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form; 2.Age >= 18 years old; 3.According to the 2016 WHO classification standards for hematopoietic and lymphoid tissue tumors, PV or ET was diagnosed; 4.According to the researchers' assessment, it is necessary to initiate or are currently undergoing cell therapy (within 12 weeks); 5.For female patients of childbearing age, the pregnancy test must be negative before the first administration of the medication, and they must be willing to take effective contraceptive measures during the study period and within 6 months after the last administration; 6.Expected survival period > 12 months; 7.Good compliance, able to cooperate in completing the research schedule and follow-up.
Exclusion criteria
Exclusion criteria: 1.Known to be allergic to interferon alpha, polyethylene glycol, or any of the drug components; 2.Having severe mental disorders, especially those with a history of severe depression or suicidal tendencies in the past; 3.Having uncontrolled autoimmune diseases, decompensated liver cirrhosis, severe heart disease (NYHA cardiac function III-IV grade), or renal insufficiency (creatinine clearance rate < 30 mL/min); 4.There are active and uncontrolled infections; 5.Having other active malignant tumors (excluding cured skin basal cell cancer or cervical carcinoma in situ); 6.Currently receiving other long-acting interferon treatments, or having participated in other interventional clinical trials within the past 3 months; 7.The researchers believe that there are no circumstances that would disqualify someone from participating in this study; 8.Expected/Has been used concurrently during the treatment with traditional Chinese medicines (including patent medicines) with clear anti-tumor effects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The complete hematological remission (CR) rate and overall response rate (ORR, including CR + PR) of PV and ET patients after treatment with pegylated interferon a-2b for 12, 24, 36 and 48 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the molecular remission rates at 24 weeks and 48 weeks of treatment;Evaluate the changes in disease-related symptoms of the patients at 24 weeks and 48 weeks (using the MPN10 scale);Evaluate the safety and tolerability of polyethylene glycol interferon a-2b (record all adverse events AE and serious adverse events SAE); | — |
Countries
China
Contacts
Public ContactBing Li
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Outcome results
None listed