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.
Name: Laboratory Biomarker Analysis
Description: Correlative studiesType: OtherTreatment (PEG-proline-interferon alpha-2b)
Name: PEG-Proline-Interferon Alfa-2b
Description: Given SCType: BiologicalTreatment (PEG-proline-interferon alpha-2b)
Name: Quality-of-Life Assessment
Description: Ancillary studiesType: OtherTreatment (PEG-proline-interferon alpha-2b)
Description: The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Measure: Best overall response (CR, PR, or CI) as determined by International Working Group Criteria Time: Up to 3 yearsDescription: The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Measure: Incidence of adverse events, as measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4) Time: Up to 3 yearsDescription: The distribution of survival time will be estimated using the method of Kaplan-Meier.
Measure: Survival time Time: Time from registration to death due to any cause, assessed up to 3 yearsDescription: Patient-reported symptoms and QOL will be described at each time point using the mean, confidence interval, median, and range. Changes in individual symptoms, changes in a symptom scale composed of symptoms specific to MF patients, and changes in the MPN TSS will be investigated. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms and QOL, as well as with clinical outcomes and clinician-assessed symptoms.
Measure: Changes in patient-reported symptoms and QOL as measured by MPN-SAF Time: Baseline to up to 3 yearsSingle Group Assignment
There is one SNP
To evaluate the impact of P1101 on bone marrow and histological features of myelofibrosis including cytogenetics, blast percentage, fibrosis, and JAK2-V617F allele burden by cohort (early vs intermediate-2/high risk). --- V617F ---