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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606.
Primary Objective:
1. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor therapy in patients with CML.
Secondary Objective:
1. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia associated with imatinib or other tyrosine kinase inhibitors
IL-11 is a hormone normally produced in your body that plays a role in stimulating the production of platelets.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a blood sample (1 teaspoon) collected to check your platelet count. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will receive one injection of IL-11 under the skin (usually of the arms, legs or abdomen) 3 times a week. If your platelet count increases, treatment will continue on this schedule as long as a platelet increase is observed. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of IL-11 injections may be increased. If the platelet count becomes high enough, treatment may be stopped but may also be restarted if necessary.
During therapy with IL-11, additional blood samples (1 teaspoon each) will be collected to measure the platelet count every week until the platelets are stable and then every 2 to 6 weeks while you are receiving treatment on study. No other tests are required for this study.
While you are on this study, you will continue your treatment with imatinib mesylate or other tyrosine kinase inhibitor as decided by your doctor for standard care.You will be taken off if there is no response to treatment or if there are unacceptable side effects. There will be no follow-up after you go off study.
This is an investigational study. The Food and Drug Administration (FDA) has approved IL-11 for use in chemotherapy-caused low platelet counts. A maximum of 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interleukin-11 | Experimental | Starting dose 10 mcg/kg subcutaneously 3 times a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin-11 (IL-11 or Neumega) | Drug | 10 mcg/kg under the skin (usually of the arms, legs or abdomen) three times weekly. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of injections may be increased. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response | Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (>/= 3 months) platelet count >/= 60 x 10^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia. | Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge E. Cortes, 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 |
|---|---|
| M.D. Anderson's Website | View source |
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Recruitment Period 10/15/05 to 9/17/07. All participants registered at The University of Texas M.D. Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interleukin-11 | Starting dose 10 mcg/kg subcutaneously 3 times a week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interleukin-11 | Starting dose 10 mcg/kg subcutaneously 3 times a week |
| 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 | Number of Participants With Complete Response | Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (>/= 3 months) platelet count >/= 60 x 10^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia. | Posted | Number | Participants | Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years) |
|
|
2 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 | Interleukin-11 | Starting dose 10 mcg/kg subcutaneously 3 times a week |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Cortes M.D./Professor | The University of Texas M. D. Anderson Cancer Center | 713/794-5783 | eharriso@mdanderson.org |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017370 | Interleukin-11 |
| C105308 | oprelvekin |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 8 |
| 5 |
| 8 |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blurry Vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |