Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis
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|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|
|Primary Completion Date :||June 2017|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|