Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Controlled Trial of Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis|
- Evidence of improved clinical status [ Time Frame: One year ] [ Designated as safety issue: No ]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.
- Progression free survival and overall survival [ Time Frame: One year ] [ Designated as safety issue: No ]Survival will be assessed at one year from time of study entry.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
No Intervention: Observation arm
Subjects will be monitored closely for disease progression, however will receive no intervention.
Experimental: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 50 micrograms once a week for up to 3 years.
Drug: Peginterferon alfa-2a
50 mcg subcutaneous injection once per week
Other Name: PEGINTRON, Interferon alfa, IFNα-2b
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758588
|Contact: Richard T Silver, M.D.||email@example.com|
|United States, Georgia|
|Emory University Hospital||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Wilena Session 404-778-5319 firstname.lastname@example.org|
|Principal Investigator: Elliott Winton, MD|
|United States, New York|
|Weill Medial College of Cornell Universiy||Recruiting|
|New York, New York, United States, 10021|
|Contact: Ruth Baumann, R.N. 212-746-4882 email@example.com|
|Principal Investigator: Richard T Silver, M.D.|
|Sub-Investigator: Ellen K Ritchie, M.D.|
|Sub-Investigator: Gail Roboz, M.D.|
|Sub-Investigator: Eric Feldman, M.D.|
|Principal Investigator:||Richard T Silver, M.D.||Weill Medical College of Cornell University|