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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The goal of this clinical research study is to see if Gleevec, known as imatinib mesylate (STI571), can improve the disease condition in patients with hypereosinophilic syndrome, polycythemia vera, atypical CML or CMML with PDGF-R fusion genes, or mastocytosis.
Imatinib mesylate is a chemical compound that blocks a protein that is responsible for a certain form of leukemia. However, imatinib mesylate also blocks other important proteins that may be responsible for other blood diseases such as myeloproliferative disorders.
Patients in this study will take 4 tablets of imatinib mesylate by mouth every day. Patients with HES will take 1 tablet daily to begin, and may go up to 4 tablets daily depending on response. Imatinib mesylate should be taken each morning at breakfast with a large glass of water. Bottles containing the tablets will be given to the patient every month. Unused supplies must be returned at the end of the study. Patients taking oral hydroxyurea to control their blood counts, can continue it during the first month of imatinib mesylate treatment, but must stop taking it from then on.
After completing 2 months of therapy, response to imatinib mesylate will be evaluated. If the response is good, treatment with imatinib mesylate alone will be continued. If the response is not good, the dose of imatinib mesylate will be increased to 8 tablets daily (4 in the morning and 4 in the evening) or may be decreased to 3 tablets daily. This will be based on how the drug is tolerated. Treatment may be continued for up to one year, or as long as it is judged best to control the leukemia.
Patients will be asked to visit their doctor for a physical exam and vital signs. The frequency of doctor visits will vary depending on physical condition.
Blood tests (about 2 teaspoons) will be done once each year. The blood samples will be used for routine lab tests. A bone marrow sample will also be taken to check and measure cells related to the disease after 3 - 4 months, then every 3-6 months in the first year. If the initial bone marrow sample does not show disease, repeated bone marrows will not be done.
This is an investigational study. Imatinib mesylate has been approved in CML for patients whose disease has not responded to interferon. However, this is an investigational study in patients with myeloproliferative diseases. The FDA has authorized the use of imatinib mesylate in research. A total of 145 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib | Experimental | Imatinib mesylate 400 mg orally daily, and in HES patients start with imatinib mesylate 100 mg orally daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib Mesylate (Gleevec) | Drug | Imatinib mesylate 400 mg orally daily, and in HES patients start with imatinib mesylate 100 mg orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Complete Response (CR) | Acute myeloid leukemia (AML), Myelodysplastic Syndromes (MDS): CR=Normalization peripheral blood & bone marrow with 5% or less blasts; normo- or hypercellular marrow; Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, & platelet count >100 x 10^9/L; or CR marrow=As per CR but platelet count < 100 x 10^9/L. Agnogenic myeloid metaplasia (AMM) & CMML: CR=Absence of signs/symptoms of disease; White blood count between 1 to 10 x 10^9/L with no peripheral blasts, promyelocytes, or myelocytes and normalization of bone marrow (< 5% blasts in normocellular or hypercellular marrow) for 4+ weeks. PV: CR=normalization of hemoglobin/hematocrit without need for phlebotomies, disappearance all signs/symptoms of disease. HES: CR=disappearance of eosinophilia (\ | after 2 months of therapy, up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Time from response to disease progression, measuring length of the response in those participants who responded. | From response evaluation (first evaluation following 2 months therapy) to disease progression or death or until disease progression whichever occurs first, up to 12 years and 5 months |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Cortes, MD | UT MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
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All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imatinib Mesylate | Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Overall Survival |
Overall survival defined as time from registration to disease progression or death from any cause. |
| From the start of therapy to death or disease progression, assessed up to 12 years and 5 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Imatinib Mesylate | Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Leukemia Diagnosis Categories | Leukemia diagnosis and any subtype determination confirmed via bone marrow aspirate and/or biopsy, assessed prior to treatment. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Complete Response (CR) | Acute myeloid leukemia (AML), Myelodysplastic Syndromes (MDS): CR=Normalization peripheral blood & bone marrow with 5% or less blasts; normo- or hypercellular marrow; Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, & platelet count >100 x 10^9/L; or CR marrow=As per CR but platelet count < 100 x 10^9/L. Agnogenic myeloid metaplasia (AMM) & CMML: CR=Absence of signs/symptoms of disease; White blood count between 1 to 10 x 10^9/L with no peripheral blasts, promyelocytes, or myelocytes and normalization of bone marrow (< 5% blasts in normocellular or hypercellular marrow) for 4+ weeks. PV: CR=normalization of hemoglobin/hematocrit without need for phlebotomies, disappearance all signs/symptoms of disease. HES: CR=disappearance of eosinophilia (\ | Posted | Number | participants | after 2 months of therapy, up to 1 year. |
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| Secondary | Duration of Response | Time from response to disease progression, measuring length of the response in those participants who responded. | Posted | Median | Full Range | Months | From response evaluation (first evaluation following 2 months therapy) to disease progression or death or until disease progression whichever occurs first, up to 12 years and 5 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival defined as time from registration to disease progression or death from any cause. | Posted | Median | Full Range | Months | From the start of therapy to death or disease progression, assessed up to 12 years and 5 months |
|
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Adverse Event collection from first treatment through 30 days following last treatment, treatment may continue up to one year without disease progression.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imatinib Mesylate | Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily. | 10 | 125 | 13 | 125 | 0 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hepatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Systematic Assessment |
| |
| Herniated disc Surgery | Surgical and medical procedures | CTCAE (2.0) | Systematic Assessment |
| |
| GI Hemorrhage | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Second Malignancy (Basal Cell Carcinoma) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hagop M Kantarjian,MD/Chair, Leukemia | University of Texas (UT) MD Anderson Cancer Center | (713) 792-7026 | hkantarjian@mdanderson.org |
| ID | Term |
|---|---|
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D011087 | Polycythemia Vera |
| D017681 | Hypereosinophilic Syndrome |
| D008415 | Mastocytosis |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009196 | Myeloproliferative Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D000090362 | Mast Cell Activation Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | 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 |
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| Chronic Myelomonocytic Leukemia (CMML) |
|
| Essential Thrombocythemia |
|
| Hypereosinophilic syndrome (HES) |
|
| Systemic mastocytosis (SM) |
|
| Myelodysplastic syndromes (MDS) |
|
| Myelofibrosis |
|
| Polycythemia Vera (PV) |
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| Title | Measurements |
|---|---|
|
| Essential Thrombocythemia |
|
| Hypereosinophilic syndrome (HES) |
|
| Systemic mastocytosis (SM) |
|
| Myelodysplastic syndromes (MDS) |
|
| Myelofibrosis |
|
| Polycythemia Vera (PV) |
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