myelofibrosis
Conditions
Interventions
1:Ruxolitinib maintains the original therapeutic dose,Luspatercept with a starting dose of 1.0mg/kg. The second titration reaches 1.33mg/kg, and the third titration reaches 1.75mg/kg
2:Ruxolitinib maintains the original therapeutic dose,Luspatercept with a starting dose of 1.33mg/kg. The second titration reaches 1.75mg/kg, and the third titration reaches 2.0mg/kg
3:Ruxolitinib maintains the original therapeutic dose,Luspatercept with a starting dose of 1.5mg/kg. The second titration reaches 2.0mg/kg, and the third titration reaches 2.5mg/kg
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? 18 years old = Age = 75 years old; ? Diagnosed as PMF, post ET MF, or post PV MF according to the 2016 World Health Organization (WHO) criteria; ? RBC infusion<9U/12 weeks before enrollment; ? After at least one type of anemia treatment (including EPO, androgens, thalidomide/lenalidomide, glucocorticoids), pre transfusion hb = 9g/dL; ? ECOG = 2; ? Willing to avoid pregnancy or childbirth based on the following criteria; ? Currently, Lucretinib is being used for treatment of over 80000; ? Female participants without fertility (i.e., those who underwent hysterectomy and/or bilateral oophorectomy for sterilization or amenorrhea for = 12 months and aged = 50 years) are eligible to participate in the study. ? Female participants with fertility must have a negative serum pregnancy test result during screening and agree to appropriate contraceptive measures from screening to safety follow-up. ? Male subjects with fertility must agree to effective contraceptive measures from screening until 93 days after the last administration of the study drug, and during this period, they are not allowed to donate sperm.
Exclusion criteria
Exclusion criteria: ? Severe liver and kidney dysfunction: a. Glomerular filtration rate3ULN; c. Direct gallbladder = 2ULN; ? Subjects with platelet count<50 * 109/L; ? Anemia caused by reasons other than bone marrow fibrosis disease itself or JAK2 inhibitor treatment; ? Use hydroxyurea, interferon, immunomodulators (such as thalidomide), androgens, EPO, or other drugs that affect hematopoietic function 4 weeks before enrollment; ? Hypertension, heart disease, or systemic fungal, bacterial, or viral infections that do not meet the treatment criteria; ? Previous history of malignant tumors (excluding those who have been cured for more than 5 years); ? Planned or previously performed hematopoietic stem cell transplantation; ? There was a history of stroke, myocardial infarction, deep vein thrombosis, or pulmonary embolism 6 months prior to enrollment. ? Participating in clinical trials of other new drugs. ? Other researchers believe that it is not suitable to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood drug concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hb;AE; | — |
Countries
China
Contacts
Public ContactNiu ting
West China Hospital of Sichuan University
Outcome results
None listed