myeloproliterative neoplasms
Conditions
Interventions
Experimental Group A:decitabine 20 mg/m2/week intravenous
Experimental Group B:decitabine 15 mg/m2/week intravenous
Control Group C:Hydroxyurea 1,000 mg/ day oral
Sponsors
The Forth Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Diagnosis of primary myelofibrosis (PMF), polycythemia vera (PV), essential thrombocytosis (ET), myeloproliferative neoplasms-not classified (MPN-U) according to WHO criteria (2016 edition), or diagnosis of post-polycythemia vera (post-PV-MF) or post-thrombocythemia MF (post-ET-MF) according to IWG-MRT criteria; 3. MDSCs >= 20% detected by flow cytometry in bone marrow mononuclear cells; 4) The expected survival time >= 24 weeks; 5. ECOG score 0-2; 6. Bone marrow or peripheral blood blasts = 1.0 x 10^9/L and platelet count >= 50 x 10^9/L within 7 days before randomization; 8. Within 7 days before randomization, the function of major organs was basically normal, that is, the following criteria were met: ALT and AST <= 2.5 x ULN; 2.0 x ULN TBIL and DBIL or less; Serum creatinine <= 1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Patients who underwent major surgery within 4 weeks; 2. Patients with epilepsy or using psychotropic or sedative drugs before screening; 3. Paitients with any chemotherapy, immunoregulatory therapy within 2 weeks before randomization; 4. Transfusion of blood within 3 weeks before randomization; 5. Patients with congestive heart failure grade III or higher (NYHA), unstable angina pectoris or myocardial infarction, cerebrovascular accident, thrombotic disease, or arrhythmogenic disease requiring treatment in the previous 6 months; 6. Patients with QTc > 480 ms; 7. Patients who had active TB infection or were at risk of TB infection in the previous 12 months; 8. Patients requiring treatment for bacterial, viral, parasitic or fungal infections (other than onychomycosis) with any clinical symptoms; 9. Malignant tumors in the past 5 years; 10. Co-existing with other serious diseases that the investigator believes may affect patient safety and compliance; 11. Any significant clinical and laboratory abnormalities that the investigator believes affect the safety evaluation of patients; 12. HIV-positive during screening, or positive for active hepatitis B virus (HBsAg positive and HBV-DNA >= 1,000 copies/mL (if the unit of HBV-DNA is IU/mL, conversion is required), or positive for anti-HCV antibody and abnormal HCV-RNA; 13. Patients who are planning to become pregnant or who are pregnant or breastfeeding and who are unable to use effective contraception throughout the trial period; 14. Patients who participated in clinical trials of other drugs or medical devices within 3 months prior.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of MDSCs andbiological activity indexes;Objective Response Rate;Myeloproliferative neoplasm (MPN)10 symptoms;Leukemia Free Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Countries
China
Contacts
Public ContactHuang Jian
The Forth Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed