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| ID | Type | Description | Link |
|---|---|---|---|
| CSTI571AUS41 | Other Grant/Funding Number | Novartis |
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The purpose of this research study is to evaluate the safety and effectiveness of patients with Polycythemia Vera treated with Gleevec.
Phlebotomy is a standard temporizing treatment for Polycythemia Vera. Performing repeated phlebotomies may lead to iron deficiency and can contribute to a rising platelet count. This may create additional problems, such as clots particularly in patients older than 50. There is reason to believe that the use of Gleevec may cause a decrease in the activity of the marrow so that patients may not require as many or any phlebotomies. Thus, spleen function may possibly improve by decreasing in size and patients' platelet counts may also improve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study drug | Experimental | Gleevec treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gleevec | Drug | 400 mg once daily for 12 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Stabilization of hematocrit | Weekly for the first six week of treatment, then monthly for one year from study entry. | |
| Platelet count maintenance a therapeutic range. | Weekly for the first six weeks of treatment, then monthly for one year from study entry. |
| Measure | Description | Time Frame |
|---|---|---|
| Splenomegaly (if existent) | Weekly for the first six weeks of treatment, then montly for one year from study entry. | |
| Quality of life, performance status, side effects and complications during treatment. | Weekly for the first six weeks of treatment, then montly for one year from study entry. |
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Inclusion Criteria:
Patients have diagnosis of Polycythemia Vera (PV). Patients may have newly diagnosed PV.
Patients may have previously interferon-alfa treated PV with documented resistance, refractoriness or intolerance to interferon-alfa.
Patients may have PV with inadequate control on hydroxyurea.
Performance status of 0, 1, or 2
Adequate end organ function, defined as the following:
Written voluntary informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Silver, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D011087 | Polycythemia Vera |
| ID | Term |
|---|---|
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| D001855 |
| Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |