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
Results First Posted : July 24, 2018
Last Update Posted : July 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myelofibrosis||Drug: Peginterferon alfa-2a||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 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
- Clinical Improvement [ Time Frame: One year ]
Clinical improvement (CI) Requires one of the following in the absence of both disease progression (as outlined below) and Complete Response (CR)/Partial Response (PR) assignment (CI response is validated only if it lasts for no fewer than 8 weeks) i. A minimum 20-g/L increase in hemoglobin level or becoming transfusion independent (applicable only for patients with baseline hemoglobin level of less than 100 g/L).
ii. Either a minimum 50% reduction in palpable splenomegaly of a spleen that is at least 10 cm at baseline or a spleen that is palpable at more than 5 cm at baseline becomes not palpable.
iii. A minimum 100% increase in platelet count and an absolute platelet count of at least 50 000 109/L (applicable only for patients with baseline platelet count below 50 109/L).
iv. A minimum 100% increase in Absolute Neutrophil Count (ANC) and an ANC of at least 0.5 109/L (applicable only for patients with baseline absolute neutrophil count below 1 109/L).
- Progression Free Survival [ Time Frame: Week 21 ]
Progression free survival is the measure of subject survival in the absence of disease progression. Disease progression is defined as progression to the next higher International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Dynamic International Prognostic Scoring System (DIPSS) stage from diagnosis. The IWG-MRT DIPSS stratifies primary myelofibrosis (PMF) into four risk categories (low, intermediate 1, intermediate 2, and high risk), based on 5 clinical factors; Age>65, Hemoglobin <10gm/dL, white blood cell (WBC)>25,000/uL, peripheral blasts>1%, and constitutional symptoms.
Progression free survival will be assessed at 21 weeks from time of study entry.
- Overall Survival [ Time Frame: Week 21 ]
Overall survival measures subject survival regardless of disease progression.
Overall survival will be assessed at 21 weeks 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|