This pilot phase II trial studies P1101 (polyethyleneglycol [PEG]-proline-interferon
alpha-2b) in treating patients with early myelofibrosis. PEG-proline-interferon alpha-2b is
a substance that can improve the body's natural response and may slow the growth of early
myelofibrosis.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- 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)
- Early stage myelofibrosis (MF) (low or intermediate 1 stage as defined by Dynamic
International Prognostic Scoring System [DIPSS])
- No prior treatment for myelofibrosis
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Platelet count >= 100,000/mm^3
- Absolute neutrophil count (ANC) >= 1000/mm^3
- Aspartate transaminase (AST) =< 2. 5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) =< 2. 5 x ULN
- Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault
formula
- 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
Exclusion Criteria:
- Patients who have had chemotherapy or radiation =< 2 weeks of registration
- Patients with evidence of intermediate 2 or high risk disease (according to DIPSS)
- Patients with a bone marrow biopsy with < 15% cellularity, evidence of collagen
fibrosis, or osteosclerosis (demonstrating advanced disease)
- Patients with intolerance to compounds similar to pegylated interferon alpha-2b
- Patients with evidence of >= grade 2 peripheral sensory neuropathy
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate
contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens
- Immunocompromised patients or patients known to be human immunodeficiency virus (HIV)
positive and currently receiving antiretroviral therapy
- Uncontrolled simultaneous illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, history of depression, or psychiatric illness/social situations that
would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment
for the primary neoplasm
- History of myocardial infarction =< 6 months prior to registration, or congestive
heart failure requiring use of ongoing maintenance therapy for life-threatening
ventricular arrhythmias
- History of significant or major fundoscopic findings including, but not limited to,
retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic
atrophy, micro-aneurysm or macular changes
- Other active malignancy at time of registration; EXCEPTIONS: non-melanotic skin
cancer or carcinoma-in-situ of the cervix