Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)

Exclusion Criteria

• •PV or ET patients who progressed while on pegylated interferon or ropeginterferon therapy.
• •Receiving other investigational agents.
• •Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt (Patients with pre-existing depression who are well-controlled and on stable doses of antidepressants are eligible).
• •Evidence of severe retinopathy or clinically significant eye disease.
• •History or presence of active serious or untreated autoimmune disease.
• •History of solid organ transplant.
• •Liver cirrhosis Child-Pugh score B or C. -≥ 5% blasts in peripheral blood or bone marrow.
• •Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
• •Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
• •The diagnosis of another malignancy which, in the investigator's opinion, is likely to significantly impact study participation.
• •Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
• •* Cardiovascular disorders:
• •* Uncontrolled hypertension, in the opinion of the investigator
• •* Congestive heart failure New York Heart Association Class II or greater, unstable angina pectoris, serious cardiac arrhythmias.
• •* Stroke or myocardial infarction within the past 3 months
• •* Significant coronary stenosis, in the opinion of the investigator
• •* QTc prolongation defined as a QTcF \> 500 ms.
• •* Known congenital long QT.
• •* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[subjects may not receive the drug through a feeding tube\], social/ psychological issues, etc.)
• •Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
• •Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
• •Active infection requiring systemic therapy, including, but not limited to: tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
• •Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• •Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
• •Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v 6.0 Grade ≥ 3).
• •Subjects taking prohibited medications as described in Section 7.8. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.