Clinical Trial: Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Randomized Controlled Trial of Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis

Brief Summary: The purpose of this study is to look at the effectiveness of giving patients who have been newly diagnosed with untreated early stage primary myelofibrosis (PMF) a study drug called PEGINTRON (also known as pegylated interferon alfa 2b). This intervention will be compared to the widely employed "watch and wait" (best supportive care) approach for early stage PMF, in which patients are followed closely and treatment initiated only if the disease progresses.

Detailed Summary: Subjects will be randomized into one of the study groups: one in which subjects get treated with PEGINTRON and the other in which subjects are closely followed and get best supportive care until disease progression (the presently accepted standard approach for early disease). Subjects on the observation arm will be carefully monitored for clinical or laboratory progression of disease during scheduled study visits. However, they will not be treated with an active drug like Interferon alfa or others such as Hydroxyurea, Revlimid, Thalidomide, Pomalidomide, and the newly approved JAK2 inhibitor Ruxolitinib (Jakafi). If their disease progresses, they will be eligible for cross-over into the treatment arm with PEGINTRON. Subjects randomized to the treatment arm will receive PEGINTRON once weekly.
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: Evidence of improved clinical status [ Time Frame: One year ]

Improved clinical status is defined as clinical improvement (CI) in the response criteria of the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and is evaluated by blood and bone marrow tests performed every 4 weeks for one year.


Original Primary Outcome: Same as current

Current Secondary Outcome: Progression free survival and overall survival [ Time Frame: One year ]

Survival will be assessed at one year from time of study entry.


Original Secondary Outcome: Same as current

Information By: Weill Medical College of Cornell University

Dates:
Date Received: December 24, 2012
Date Started: January 2013
Date Completion: January 2017
Last Updated: May 19, 2016
Last Verified: May 2016