myelofibrosis
Conditions
Interventions
Observation Group:Luspatercept 1.0mg/kg ,injection every 21 days,Two injections
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? 18 = 75 years old; ? PMF, post et MF or post PV MF were diagnosed according to the 2016 World Health Organization (who) criteria; ? RBC infusion < 12U / 12 weeks before enrollment; ? After at least one anemia treatment (including EPO, androgen, thalidomide / lenalidomide, glucocorticoid), use alone or in combination with multiple drugs, Hb = 8g/dl before blood transfusion; ? ECoG = 2; ? Be willing to avoid pregnancy or childbirth according to the following criteria. a. Female study participants who were infertile (i.e., surgically sterilized by hysterectomy and / or bilateral oophorectomy or amenorrhea = 12 months and aged = 50 years) were eligible to participate in the study. b. Female research participants with fertility must have negative serum pregnancy test results at the time of screening and must agree to take appropriate contraceptive measures from screening to safety follow-up. c. Male research participants with fertility must agree to take effective contraceptive measures from screening to 93 days after the last administration of study drugs, and shall not donate sperm during this period;
Exclusion criteria
Exclusion criteria: ? Severe liver and kidney dysfunction: A. glomerular filtration rate 3uln; c. Straight bile = 2uln; ? Study participants with < 50 platelets; ? Anemia caused by other causes besides myelofibrosis disease itself or JAK2 inhibitor treatment; ? Hypertension, heart disease or systemic fungal, bacterial or viral infections that do not meet the treatment standard; ? Previous history of malignant tumor (except those who have been cured for more than 5 years); ? Hematopoietic stem cell transplantation has been performed in the plan or before; ? There was a history of stroke, myocardial infarction, deep vein thrombosis or pulmonary embolism 6 months before enrollment. ? They are participating in clinical trials of other new drugs. ? Other researchers think it is not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactWu Yu
West China Hospital,Sichuan University
Outcome results
None listed