Ruxolitinib vs Allogeneic SCT for Patients With Myelofibrosis According to Donor Availability

Prior treatment

• Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment

Other illness

• Positive serology for HIV
• Uncontrolled invasive fungal infection at time of screening (baseline)
• Serious psychiatric or psychological disorders

Lab values

• Severe renal, hepatic, pulmonary or cardiac disease, such as:
  • Total bilirubin, SGPT or SGOT \> 3 times upper the normal level
  • Left ventricular ejection fraction \< 30 %
  • Creatinine clearance \< 30 ml/min
  • DLCO \< 35 % and/or receiving supplementary continuous oxygen
• Pregnant or lactating women (positive serum pregnancy test)

Age

• Age \< 18 and ≥ 71 years.

Other

• Transformation to AML

• Symptomatic primary myelofibrosis or myelofibrosis post polycythaemia vera or essential thrombocythemia stage intermediate 2- or high-risk according to IPSS or DIPSS \[46\] or intermediate 1-risk with high risk cytogenetics, other than normal karyotype, sole del 20q, del 13q, or sole+9, or transfusion-dependency
• Patients age: 18 - 70 years at time of inclusion (female and male)
• Patients understand and voluntarily sign an informed consent form
• Platelet count ≥ 50 x 109/L
• No prior Ruxolitinib treatment
• ECOG ≤ 2