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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01905 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The goal of this clinical research study is to learn if eltrombopag can help to increase the number of platelets in patients with CLL. The safety of this drug will also be studied.
The Study Drug:
When the number of platelets in your body gets too low, it can cause bleeding, which may cause serious health problems and/or prevent you from receiving chemotherapy. Eltrombopag is designed to act like a protein in your body that helps make platelets. This may help increase your platelet counts.
Study Drug Administration:
You will take pills of the study drug by mouth 1 time each day on an empty stomach (1 hour before or 2 hours after a meal). You should take the pills with 1 cup (8 ounces) of water. You should wait at least 4 hours between taking eltrombopag and eating foods with calcium (dairy products and/or juices with added calcium) or taking drugs/supplements with iron, calcium, aluminum, magnesium, selenium and/or zinc. Other drugs may also affect eltrombopag. Be sure to tell your doctor about any drugs and/or supplements you may be taking.
During your study visits, your doctor will check your platelet counts to see if they improve. If they do not improve, your dose of study drug may be increased. Your doctor will instruct you on each dose of eltrombopag you should take.
Do not take more than 1 dose of eltrombopag on any one day. If you forget to take a dose, you should skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Study Visits:
Each study "cycle" will be 28 days.
Each week during Cycle 1, then every 2 weeks during Cycles 2 and 3:
On Day 1 (+/- 7 days) of Cycles 4 and beyond:
Length of Study Participation:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if you require other treatment for CLL or if intolerable side effects occur.
Follow-Up:
After you stop taking eltrombopag for any reason, your platelet counts may drop. This may increase your risk of bleeding. Blood (about 1 tablespoon) will be drawn each week for 4 weeks to check your platelet counts.
This is an investigational study. Eltrombopag is FDA approved and commercially available for use in chronic immune thrombocytopenic purpura (ITP - severe bleeding due to platelet destruction by the immune system). The use of this drug in patients with CLL is investigational.
Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eltrombopag | Experimental | Starting dose 75 mg by mouth (PO) daily for 28 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | Starting dose 75 mg by mouth (PO) daily for 28 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Response | Response is Complete Response (CR) + Major Response (MR). Complete response was defined as an increase in platelet count to ≥100K/µL for at least 4 weeks. Major response was defined as an increase in platelet count from <20K/µL to ≥20K/μL and by at least 100% for at least 8 weeks; or for pts starting with >20K/μL platelet count, absolute increase in platelet count of ≥30K/μL for at least 4 weeks. | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to CLL Progression Requiring Leukemia Treatment | The number of months from start of treatment to CLL progression, requiring leukemia treatment. Disease Progression (PD) is defined as a >/= 50% increase in at least one of the following in responding participants: >/= 2 lymph nodes (on 2 exams 2 weeks apart), liver or spleen (below costal margin) , or absolute number of circulating lymphocytes (>/= 10L/ul). |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William G. Wierda, MD, PHD, BS | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eltrombopag | Starting dose 75 mg by mouth (PO) daily for 28 day cycle. Eltrombopag: Starting dose 75 mg by mouth (PO) daily for 28 day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eltrombopag | Starting dose 75 mg by mouth (PO) daily for 28 day cycle. Eltrombopag: Starting dose 75 mg by mouth (PO) daily for 28 day cycle |
| 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 | Number of Participants With a Response | Response is Complete Response (CR) + Major Response (MR). Complete response was defined as an increase in platelet count to ≥100K/µL for at least 4 weeks. Major response was defined as an increase in platelet count from <20K/µL to ≥20K/μL and by at least 100% for at least 8 weeks; or for pts starting with >20K/μL platelet count, absolute increase in platelet count of ≥30K/μL for at least 4 weeks. | Posted | Count of Participants | Participants | Up to 4 years |
|
|
Up to 4 years
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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 | Eltrombopag | Starting dose 75 mg by mouth (PO) daily for 28 day cycle. Eltrombopag: Starting dose 75 mg by mouth (PO) daily for 28 day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weakness | General disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperbilirubinemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Wierda MD/Professor | The University of Texas MD Anderson Cancer Center | 713-745-0428 | wwierda@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2010 | Feb 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D013921 | Thrombocytopenia |
| C537560 | Jacobs syndrome |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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| Up to 4 years |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Time to CLL Progression Requiring Leukemia Treatment | The number of months from start of treatment to CLL progression, requiring leukemia treatment. Disease Progression (PD) is defined as a >/= 50% increase in at least one of the following in responding participants: >/= 2 lymph nodes (on 2 exams 2 weeks apart), liver or spleen (below costal margin) , or absolute number of circulating lymphocytes (>/= 10L/ul). | Posted | Median | Full Range | Months | Up to 4 years |
|
|
|
| 2 |
| 23 |
| 6 |
| 23 |
| 23 |
| 23 |
| Cellulitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Altered Mental Status | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Blurred Vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Splenectomy | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
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| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| 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 |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |