Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493181
Status:
COMPLETED
Last Update Posted:
2012-02-20
First Post:
2007-06-26
Brief Title:
Interleukin 11 Thrombocytopenia Imatinib in Chronic Myelogenous Leukemia CML Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
The Effect of Interleukin 11 on Thrombocytopenia Associated With Imatinib or Other Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 careYou 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
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 careYou 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None