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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Hoffmann-La Roche |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00452023 |
The goal of this clinical research study is to see if Pegasys (IFN-alpha2a) can help to control the disease in patients with ET, PV, AMM/MF, and Ph-negative CML. The safety of this treatment will also be studied.
Condition | Intervention | Phase |
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Myeloproliferative Disorders |
Drug: IFN-alpha2a |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | PEG IFN-alpha2a (Pegasys®) Therapy in Patients With Chronic Myeloproliferative Diseases (Excluding Philadelphia Chromosome Positive Chronic Myeloid Leukemia) |
Estimated Enrollment: | 280 |
Study Start Date: | April 2005 |
Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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IFN-alpha2a: Experimental |
Drug: IFN-alpha2a
90 microgram (mcg) injection under the skin once a week
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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a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Srdan Verstovsek, MD | 713-745-3429 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Srdan Verstovsek, MD |
Principal Investigator: | Srdan Verstovsek, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Srdan Verstovsek, MD / Associate Professor ) |
Study ID Numbers: | DM03-0109 |
Study First Received: | March 22, 2007 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00452023 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Myeloproliferative Disorders Essential Thrombocythemia Polycythemia Vera Pegasys |
IFN-alpha2a Pegylated-Interferon Alpha-2A PEG-IFNa-2a |
Interferon-alpha Polycythemia Polycythemia Vera Philadelphia Chromosome Anti-Infective Agents Immunologic Factors Hematologic Diseases Interferons Myeloproliferative Disorders Leukemia, Myeloid Angiogenesis Inhibitors Antiviral Agents |
Leukemia Chronic Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Thrombocytosis Peginterferon alfa-2a Hemorrhagic Thrombocythemia Thrombocythemia, Hemorrhagic Essential Thrombocytosis Chronic Myelogenous Leukemia Interferon Alfa-2a Bone Marrow Diseases |
Interferon-alpha Anti-Infective Agents Immunologic Factors Antineoplastic Agents Hematologic Diseases Growth Substances Physiological Effects of Drugs Myeloproliferative Disorders Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Peginterferon alfa-2a Growth Inhibitors Angiogenesis Modulating Agents Bone Marrow Diseases Interferon Alfa-2a |