Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

Inclusion Criteria

Written informed consent must be obtained prior to any screening procedures.

• Male or female patients aged ≥ 18 years of age.
• Patients must have been diagnosed with PMF, according to the 2016 revised International Standard Criteria, PPV MF or PET-MF, irrespective of JAK2 mutation status.
• Patients must have had palpable splenomegaly that is equal to or greater than 5 cm below the left costal margin.
• Patients must have had hemoglobin less than 10 g/dL
• Patients must have had a history of transfusions must have a documented transfusion record in the previous 12 weeks to baseline.
• Patients must have had ECOG performance status of 0, 1, or 2.
• Patients must have had a peripheral blood blast percentage count of 2.5 x ULN;
• Aspartate aminotransferase (AST) > 2.5 x ULN.
• Patients who were being treated concurrently with a strong (potent) systemic inhibitor or inducer of CYP3A4 at the time of Screening.
• Presence of active bacterial, fungal, parasitic, or viral infection which requires therapy.
• Known history of human immunodeficiency virus (HIV) infection or other immunodeficiency syndromes such as X-linked agammaglobulinemia and common variable immune deficiency.
• Acute viral hepatitis or active chronic hepatitis B or C infection. Patients with inactive chronic infection (without viral replication) can be enrolled
• History of progressive multifocal leuko-encephalopathy.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ruxolitinib .
• History or current diagnosis of uncontrolled or significant cardiac disease, including any of the following:
• Myocardial infarction within last 6 months
• Uncontrolled congestive heart failure
• Unstable angina within last 6 months
• Clinically significant (symptomatic) cardiac arrhythmias (e.g. bradyarrhythmias, sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker)
• Significant concurrent, uncontrolled medical condition which, in the investigator's opinion, would have jeopardized the safety of the patient or compliance with the protocol.
• Patients who were undergoing treatment with another investigational medication or had been treated with an investigational medication within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
• Patients who had a history of malignancy in the past 3 years, except for treated early stage squamous or basal cell carcinoma.
• Patients who were unable to comprehend or are unwilling to sign an ICF.
• Pregnant or nursing (lactating) women
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using highly effective methods of contraception throughout the study duration inclusive of 30 day safety follow up.