Pegasys® in Patients With Myeloproliferative Diseases
The goal of this clinical research study is to see if Pegasys (IFN-alpha2a) can help to control the disease in patients with essential thrombocytosis (ET), polycythemia vera (PV), agnogenic myeloid metaplasia/myelofibrosis (AMM/MF), or Philadelphia chromosome-negative chronic myeloid leukemia (Ph-negative CML). The safety of this treatment will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PEG IFN-alpha2a (Pegasys®) Therapy in Patients With Chronic Myeloproliferative Diseases (Excluding Philadelphia Chromosome Positive Chronic Myeloid Leukemia)|
- Number of Patients with Complete Response (CR) or Partial Response (PR) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
CR = Reduction of PLT to <440x109/l and disappearance of thromboembolic events, without the use of anagrelide or hydroxyurea
PR = Reduction of PLT by 50% but still >440x109/l or reduction of thromboembolic events by 50%, without the use of anagrelide or hydroxyurea
|Study Start Date:||April 2005|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Starting dose 90 microgram (mcg) injection under the skin once a week.
Starting dose 90 microgram (mcg) injection under the skin once a week
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a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452023
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Srdan Verstovsek, MD||M.D. Anderson Cancer Center|