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Pegasys® in Patients With Myeloproliferative Diseases

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myeloproliferative Disorders

Intervention: IFN-alpha2a (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Srdan Verstovsek, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Summary

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.

Clinical Details

Official title: PEG IFN-alpha2a (Pegasys«) Therapy in Patients With Chronic Myeloproliferative Diseases (Excluding Philadelphia Chromosome Positive Chronic Myeloid Leukemia)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Patients with Complete Response (CR) or Partial Response (PR)

Detailed description: 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a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Following diagnoses: - -ET: Patients with PLT > 600 x10 9 /l documented in the past 12

months; hyperplasia of marrow megakaryocytes in the absence of identifiable cause of thrombocytosis and in the absence of Ph chromosome. Patients with ET and lower PLT

will be eligible if attributable to prior ET therapy. - -PV: Patients should have Hb

>/= 15g/dl (except if patient is having phlebotomies done) and documented past diagnosis. 2. Performance status 3 years. 3. Patients with history of ischemic retinopathy. 4. Patients with history of severe cardiac disease: NYHA Functional Class III or IV, myocardial infarction within 6 months, uncontrolled ventricular tachyarrhythmias or unstable angina. 5. Patients with history of medically significant psychiatric disease if not controlled, especially endogenous depression (does not include reactive depression post-cancer diagnosis), psychosis and bipolar disease. 6. Patients with seizure disorders requiring anticonvulsant therapy. 7. Patients with known infection with HBV, HIV, or other active systemic infection. 8. Patients with known autoimmune disease except for rheumatoid arthritis. 9. Patients with renal disease on hemodialysis. 10. Patients taking continuous or chronic high-dose systemic steroids; if discontinued, there must be a minimum washout period of one month before study drug is begun. 11. Patients with known hypersensitivity to PEG-IFN alpha-2a or its components.

Locations and Contacts

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: April 2005
Last updated: November 17, 2014

Page last updated: August 23, 2015

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