myeloproliterative neoplasms
Conditions
Interventions
MPN-AP:desitabine
MPN-AP:ruxolitinib+desitabine
MPN-BP:desitabine+half does of CAG
MPN-BP:ruxolitinib+desitabine+half does of CAG
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patients signed the informed consent, and the subjects fully understood and could comply with the requirements of the study protocol and were willing to complete the study as planned. 2. Aged 18 years or more. 3. MPN-AP/BP patients(MPN-AP is defined as patients with PV, ET and PMF whose original cells in peripheral blood or bone marrow accounted for 10%-19%,MPN-BP is defined as PV, ET and PMF patients with >=20% original cells in peripheral blood or bone marrow). 4. ECOG score <=3. 5. Acceptable prestudy organ function during screening was defined as:TBil<5 times ULN,AST and ALT <= 5 times ULN, Scr <=1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. In addition to hydroxyurea, patients received chemotherapy or research therapy within 4 weeks prior to the study. The use of rucotinib as a single drug has not been ruled out in the past. As long as other inclusion/exclusion criteria are met 2. The clinical biochemical indicators were 20% higher than the upper limit of the normal range in the laboratory 3. Heart disease within three months before screening, including New York heart association (NYHA) class III/IV congestive heart failure, drug treatment of arrhythmia or myocardial infarction, or known to increase the risk of thrombotic events arrhythmia such as atrial fibrillation, or subjects after correction of QT interphase (QTc) extension (QTc > 450 milliseconds, or bundle branch block subjects QTc > 480 milliseconds). 4. The subjects were pregnant or lactating. 5. Other medications, severe acute/chronic medical or psychiatric disorders, or laboratory abnormalities may increase the risk associated with participation in the study or management of the study medication, or may interfere with the interpretation of the study results, which in the investigator's judgment will render the subject unfit to enter the study. 6. Human immunodeficiency virus infection, acquired immunodeficiency syndrome, tuberculosis are known. 7. Active hepatitis b or c or other active infections are known. 8. Female subjects who were fertile and did not use appropriate contraceptive methods during the study period and within 1 month after the last administration of the study drug. Appropriate methods of contraception are defined as methods that have a very low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injections, combination oral contraceptives, some intrauterine devices, abstinence, or partner vasectomy. Non-fertility included surgical sterilization at least 6 months before the study, or menopause defined as at least 12 months after menopause. 8. Subject's ability to sign informed consent and/or comply with study procedures and/or other conditions that make them unfit to participate in the study, in the opinion of the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Countries
China
Contacts
Public ContactBai Jie
The Second Hospital of Tianjin Medical University
Outcome results
None listed