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Report for Clinical Trial NCT02370329

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT02370329 Primary Myelofibrosis Secondary Myelofibrosis
MeSH: Primary Myelofibrosis

3 Interventions

Name: Laboratory Biomarker Analysis

Description: Correlative studies

Type: Other

Treatment (PEG-proline-interferon alpha-2b)

Name: PEG-Proline-Interferon Alfa-2b

Description: Given SC

Type: Biological

Treatment (PEG-proline-interferon alpha-2b)

Name: Quality-of-Life Assessment

Description: Ancillary studies

Type: Other

Treatment (PEG-proline-interferon alpha-2b)

Primary Outcomes

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 years

Secondary Outcomes

Description: 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 years

Description: 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 years

Other Outcomes

Description: 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 years

Purpose: Treatment

Single Group Assignment

There is one SNP


1 V617F

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 ---

HPO Nodes