Phase II randomized controlled trial of pegylated interferon alpha-2b in early primary myelofibrosis
Study Status
Open to Enrollment
Study Description
The purpose of this clinical trial is to study the effectiveness of giving the drug PEGINTRON (also known as pegylated interferon alfa 2b) to patients with untreated early stage primary myelofibrosis (PMF). 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 only initiated if the disease progresses.
Because PMF is minimally symptomatic in its early stages, there are differing opinions about whether patients derive long term clinical benefits from starting treatment early as opposed to waiting until more advanced, symptomatic stages. A small pilot study at Weill Cornell Medical College presented evidence that initiating treatment for early stage PMF resulted not only in clinical improvement but also reversal of bone marrow abnormalities. However it is unclear from this small study if the observed benefits are clinically meaningful in the long term and whether the side effects of starting treatment early are worth these benefits in the long run.
PEGINTRON is a type of interferon, which is a form of a hormone produced naturally in the body which reduces the production of blood cells. It is a drug that has been shown to have multiple therapeutic benefits in PMF.
Patients will be randomized into one of two study arms:
Arm 1: patients are treated with PEGINTRON
Arm 2: patients are closely followed and get best supportive care until disease progression (the presently accepted standard approach for early disease)
There will be 2 patients in the treatment arm for every 1 person in the observation arm.
Disease Status and/or Stage
Low or Intermediate Stage Primary Myelofibrosis (PMF)
Sponsor
Weill Cornell Medical College
Key Eligibility
- Age 18 and older
- Low or intermediate stage primary myelofibrosis (PMF)
- No prior therapy for primary myelofibrosis
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Yulia Dault, RN
- (212) 746-4829
- [email protected]
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
