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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01562 | Other Identifier | Clinical Trials Reporting Program |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The goal of this clinical research study is to learn if dasatinib can help to control Chronic Lymphocytic Leukemia (CLL). The safety of the drug will also be studied.
Optional Procedures: You will be asked to have additional blood samples drawn. These samples will be used to see how the disease is responding to the drug.
Dasatinib is designed to interfere with a type of protein that appears to be important for the survival of CLL cells.
If you are found to be eligible to take part in this study, you will take dasatinib by mouth twice a day. You will be instructed to take dasatinib in the morning and in the evening.
You will have an electrocardiogram (ECG-a test of the electrical activity of your heart) and a physical exam once every 3 months while on study. Blood (about 2-3 teaspoons) will be drawn for routine tests once a week for 1 month and then once a month for the rest of your treatment on this study. A bone marrow biopsy and aspiration will be performed, as needed, to check the status of the disease. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
Dasatinib will be given for as long as you are responding. You will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. Dasatinib is not FDA-approved for CLL, and it has been authorized for use in research only. Up to 25 patients will take part in this multicenter study. Up to 25 will be enrolled at M. D. Anderson.
Optional Procedures: If you agree, blood samples (about 2 tablespoons each time) will be collected before therapy starts, at 3-4 hours after the first dose, and at 3 months on therapy. These blood draws will be done when other routine tests are done. No additional needle sticks will be needed. The blood will be used to see how the disease is responding to the drug.
You do not have to agree to take part in the optional procedures in order to receive treatment on this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib | Experimental | Dasatinib 50mg Orally twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib (BMS-354825) | Drug | 50mg Orally twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Objective Response | Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: > 50% decrease; Liver/Spleen CR: Not palpable; PR: > 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: >1,500/μl, PR: > 1,500/μl or >50% improvement from baseline; Platelets for CR: >100,000/μl, PR: >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused) for CR: >11,0 g/dl; PR: >11.0 g/dl or >50% improvement from baseline; Lymphocytes for CR: <4,000/μl and PR: >50% decrease; Bone Marrow aspirate for CR: <30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: < 30% lymphocytes with residual disease on biopsy for nodular PR. | up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan O'Brien, MD | M.D. 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 |
|---|---|
| UT M.D. Anderson's Website | View source |
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Recruitment Period: 8/14/2006 through 11/28/2012. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib | Dasatinib 50mg Orally twice daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib | Dasatinib 50mg Orally twice 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 |
| 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 | Participants With Objective Response | Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: > 50% decrease; Liver/Spleen CR: Not palpable; PR: > 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: >1,500/μl, PR: > 1,500/μl or >50% improvement from baseline; Platelets for CR: >100,000/μl, PR: >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused) for CR: >11,0 g/dl; PR: >11.0 g/dl or >50% improvement from baseline; Lymphocytes for CR: <4,000/μl and PR: >50% decrease; Bone Marrow aspirate for CR: <30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: < 30% lymphocytes with residual disease on biopsy for nodular PR. | Three participants were not evaluable for response due to early discontinuation of treatment (0-3 days). | Posted | Number | Participants | up to 3 months |
|
6 Years, 3 Months
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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 | Dasatinib 50mg Orally twice daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan O'Brien, MD/ Professor | The University of Texas MD Anderson Cancer Center | 713-792-7543 | eharriso@mdanderson.org |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015463 | Leukemia, Prolymphocytic |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Dasatinib | Dasatinib 50mg Orally twice daily. |
|
|
| 3 |
| 17 |
| 17 |
| 17 |
| Supraventricular Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| flushing | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| 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 |