Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis
|ClinicalTrials.gov Identifier: NCT01758588|
Recruitment Status : Terminated (This study was suspended due to insufficient subject accrual.)
First Posted : January 1, 2013
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myelofibrosis||Drug: Peginterferon alfa-2a||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Randomized Controlled Trial of Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
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
- 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.
- Progression free survival and overall survival [ Time Frame: One year ]Survival will be assessed at one year from time of study entry.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758588
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|United States, New York|
|Weill Medial College of Cornell Universiy|
|New York, New York, United States, 10021|
|Principal Investigator:||Richard T Silver, M.D.||Weill Medical College of Cornell University|