myelofibrosis
Conditions
Interventions
single arm:Ruxolitinib combined with Prednisone, Thalidomide and Danazol
Sponsors
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects eligible for inclusion in this study have to meet all of the following criteria: 1) Male or female aged 18 to 65 years; Has an Eastern Oncology Cooperative Group (ECOG) performance status 0-2; 2) Diagnosed with PMF or post-PV-MF or post-ET-MF according to the 2016 World Health Organization criteria; 3) Must be at least intermediate risk-1 and above for treatment of myelofibrosis according to DIPSS(with one or more prognostic factors); 4) Absolute neutrophil count >= 1.0x10^9/L; 5) Subjects must have no plan to hematopoietic stem cell transplantation recently, they are neither candidates nor because there are no suitable donors; 6) The most prominent part of the patients spleen must be greater than or equal to 5cm from the lower edge of the rib; 7) Peripheral blood blast less than 10%; 8) Hepatic and renal function as measured by the following laboratory criteria: Aspartate transaminase (AST) and Alanine transaminase (ALT) <1.5 ULN; Serum Creatinine <= 2.0mg/dL (176.82mmol/L);Total bilirubin <2 ULN; 9) Subjects who have used other MPN drugs need to stop taking drug for more than 1 week,subjects who have undergone major surgery require surgery for more than 4 weeks; 10) Femal subjects agree to the use the adequate barrier methods of contraception (intrauterine device contraception pills or condom(maintained throughout the study and for at least 6 months after study treatment discontinuation; have a negative serum pregnancy test within 7days before taking drugs, and must be non-lactating patients; male subjects agree to the use the barrier methods of contraception.
Exclusion criteria
Exclusion criteria: Subjects eligible for this study must not meet any of the following criteria: 1) Subjects with any malignancy must be fully recovered from treatment of other malignancies and there is on evidence of persistent lesions; 2) Subjects with factors affecting oral medications (cannot be swallowedpostoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction); 3) Subjects with the history of psychotropic substance abuse and unable to quit or has a mental disorder; 4) Subjects with HBsAg positivity, HBcAb positivity or HBV-DNA above the ULN, HCV antibody positivity, HIV antibody positivity; 5) Subjects with immunodeficiency such as acquired, congenital immunodeficiency disease, or have the history of organ transplantation; 6) Subjects with any apparent history of congenital or acquired bleeding disorders. 7) Subjects with history of events of artery/venous thrombosis,such as cerebrovasucular accidents(including temporary ischemia attacks), deep vein thrombosis,and pulmonary embolism. 8) Subjects underwent spleen radiation therapy within 12 months prior to screening. 9) Subjects have previously received glucocorticoid therapy. 10) Subjects with clinically significant bacterial, fungal, parasitic or viral infection which requires therapy. Subjects with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed. 11) Subjects with obvious cardiovascular disease, such as heart failure with NYHA class 2 and above ,unstable angina in the past 3 months, myocardial ischemia or myocardial infarction,arrhythmia, and grade 1cardiac insufficiency. 12) Subjects with uncontrolled hypertension or diabetis after durg therapy. 13) Pregnant or nursing (lactating) women. 14) Subjects with the history of allergies to prednisone,thalidomide or danazol 15) Subjects who have previously received treatment with Ruxolitinib or other JAK inhibitors. 16) Subjects with serious concomitant disease than endanger the safety of the patient or affect the patientss completion of the study,in the investigators opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| cytofenetic response rate;molecular biological response; | — |
Countries
China
Contacts
Public ContactZhijian Xiao
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed