Phase II Study of P1101 in Early Myelofibrosis
This pilot phase II trial studies P1101 (polyethyleneglycol \[PEG\]-proline-interferon alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of myelofibrosis.
• Evaluable myelofibrosis by IWG-MRT criteria including one or more of the following:
‣ Spleen \>= 5 cm below the left costal margin
⁃ MPN-SAF total symptom score (TSS) \> 10 at baseline
⁃ Hemoglobin \< 10 g/dL
• Confirmed diagnosis of myelofibrosis (primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera) by World Health Organization (WHO) diagnostic criteria (3 major and 2 minor criteria: major criteria: megakaryocyte proliferation and atypia with either reticulin and/or collagen fibrosis, not meeting criteria for chronic myelogenous leukemia \[CML\], polycythemia vera \[PV\], myelodysplastic syndrome \[MDS\], or other myeloid neoplasm, JAK2V617F or other clonal marker or no evidence of reactive marrow fibrosis; minor criteria: leukoerythroblastosis, increased lactate dehydrogenase \[LDH\], anemia, palpable splenomegaly)
• For cohort 1: early stage MF (low or intermediate 1 stage as defined by Dynamic International Prognostic Scoring System \[DIPSS\]) without currently available treatment options
• For cohort 2: intermediate-2 or high risk MF patients as defined by DIPSS either not eligible for ruxolitinib or having failed under ruxolitinib
• No prior treatment for myelofibrosis (for cohort 1 only)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Platelet count \>= 100,000/mm\^3 (obtained =\< 14 days prior to registration)
• Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 14 days prior to registration)
• Aspartate transaminase (AST) =\< 2.5 x upper limit of normal (ULN) (obtained =\< 14 days prior to registration)
• Alanine aminotransferase (ALT) =\< 2.5 x ULN (obtained =\< 14 days prior to registration)
• Calculated creatinine clearance must be \>= 50 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)
• Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
• Ability to complete questionnaire(s) by themselves or with assistance
• Provide informed written consent
• Willing to return to enrolling institution for follow-up
• Willing to provide blood samples for correlative research purposes