PEG IFN-alpha2a (Pegasys®) Therapy in Patients With Chronic Myeloproliferative Diseases (Excluding Philadelphia Chromosome Positive Chronic Myeloid Leukemia)
IFN-alpha2a has been used for the treatment of a variety of disorders (such as hepatitis C).
IFN-alpha2a is a drug that may affect the way infections and malignant diseases develop.
Before treatment starts, you will have blood (around 2 teaspoons) and bone marrow samples
collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with
anesthetic and a small amount of bone marrow is withdrawn through a large needle. These
samples will be used for tests to confirm the diagnosis of the disease. Women who are able
to have children must have a negative blood pregnancy test.
During treatment, you will receive IFN-alpha2a as an injection under the skin once a week.
You (or your caregiver) will be taught how to give the injections, and you will receive
treatment on an outpatient basis.
Treatment will continue (injections once a week) as long as the disease does not get worse.
If the disease gets worse or you experience any intolerable side effects, you will be taken
off the study and your doctor will discuss other treatment options with you.
During treatment you will have blood (around 1 teaspoon) collected every other week for 2
months, then once every 1 or 2 months for a year, then every 3 months. You will also have
bone marrow samples collected every 3 to 6 months during the first year of treatment. After
the first year of treatment, bone marrow samples will be collected only when your doctor
feels they are needed. The blood and bone marrow samples will be used for tests to check on
the response to therapy.
This is an investigational study. IFN-alpha2a has been approved by the FDA for the
treatment of hepatitis C and is commercially available. However the use of IFN-alpha2a in
this study is investigational. The commercial prepartion of IFN-alpha2a(Pegasys) will be
used in this study. Up to 280 participants will take part in this study. All will be
enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Complete or Partial Response
Srdan Verstovsek, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|