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| ID | Type | Description | Link |
|---|---|---|---|
| CA 180-045 |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Dana-Farber Cancer Institute | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib treatment | Experimental | All patients were treated with dasatinib pills by mouth as treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Objective Response | Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria): Complete response (CR) requires all of the following for a period of at least 2 months:
Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease Partial response (PR): requires at least the following:
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | The number of participants with a 100% reduction in nodal mass. | 1 year |
| Median Time to Disease Progression | The median time to disease progression, measured from the start of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Amrein, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
Patients signing the consent form were screened for eligibility. If eligible, they were started on protocol. This is a single-arm protocol.
Started recruitment 12/2006 and ended recruitment 12/2008. Patients were recruited from the clinics of the Massachusetts General Hospital and the Dana Farber Cancer Institute.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib Treatment | All patients were treated with Dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib Treatment | All patients were treated with Dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Overall Objective Response | Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria): Complete response (CR) requires all of the following for a period of at least 2 months:
Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease Partial response (PR): requires at least the following:
| Posted | Number | participants who responded | 2 years |
|
From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks.
Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
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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 | Dasatinib Treatment | All patients were treated with dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philip C. Amrein, M.D. | Massachusetts General Hospital | 617-726-8748 | pamrein@partners.org |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| 1 year |
| Median Overall Survival | The median survival time, as measured from the start of treatment until death from any cause. | 3 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Complete Response Rate | The number of participants with a 100% reduction in nodal mass. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Median Time to Disease Progression | The median time to disease progression, measured from the start of treatment. | Posted | Median | Full Range | Months | 1 year |
|
|
|
| Secondary | Median Overall Survival | The median survival time, as measured from the start of treatment until death from any cause. | Posted | Median | Full Range | Months | 3 years |
|
|
|
| 2 |
| 15 |
| 10 |
| 15 |
| 15 |
| 15 |
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Nausea /vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |