Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038675
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2002-06-04
Brief Title:
Therapy of HES PV Atypical Chronic Myelocytic Leukemia CML or Chronic Myelomonocytic Leukemia CMML and Mastocytosis With Imatinib Mesylate
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Therapy of Hypereosinophilic Syndrome Polycythemia Vera Atypical CML or CMML With Platelet Derived Growth Factor PDGF-R Fusion Genes or Mastocytosis With Imatinib Mesylate STI571
Status:
COMPLETED
Status Verified Date:
2021-12
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 see if Gleevec known as imatinib mesylate STI571 can improve the disease condition in patients with hypereosinophilic syndrome polycythemia vera atypical CML or CMML with PDGF-R fusion genes or mastocytosis
Detailed Description:
Imatinib mesylate is a chemical compound that blocks a protein that is responsible for a certain form of leukemia However imatinib mesylate also blocks other important proteins that may be responsible for other blood diseases such as myeloproliferative disorders
Patients in this study will take 4 tablets of imatinib mesylate by mouth every day Patients with HES will take 1 tablet daily to begin and may go up to 4 tablets daily depending on response Imatinib mesylate should be taken each morning at breakfast with a large glass of water Bottles containing the tablets will be given to the patient every month Unused supplies must be returned at the end of the study Patients taking oral hydroxyurea to control their blood counts can continue it during the first month of imatinib mesylate treatment but must stop taking it from then on
After completing 2 months of therapy response to imatinib mesylate will be evaluated If the response is good treatment with imatinib mesylate alone will be continued If the response is not good the dose of imatinib mesylate will be increased to 8 tablets daily 4 in the morning and 4 in the evening or may be decreased to 3 tablets daily This will be based on how the drug is tolerated Treatment may be continued for up to one year or as long as it is judged best to control the leukemia
Patients will be asked to visit their doctor for a physical exam and vital signs The frequency of doctor visits will vary depending on physical condition
Blood tests about 2 teaspoons will be done once each year The blood samples will be used for routine lab tests A bone marrow sample will also be taken to check and measure cells related to the disease after 3 - 4 months then every 3-6 months in the first year If the initial bone marrow sample does not show disease repeated bone marrows will not be done
This is an investigational study Imatinib mesylate has been approved in CML for patients whose disease has not responded to interferon However this is an investigational study in patients with myeloproliferative diseases The FDA has authorized the use of imatinib mesylate in research A total of 145 patients will take part in this study All will be enrolled at MD Anderson
Patients in this study will take 4 tablets of imatinib mesylate by mouth every day Patients with HES will take 1 tablet daily to begin and may go up to 4 tablets daily depending on response Imatinib mesylate should be taken each morning at breakfast with a large glass of water Bottles containing the tablets will be given to the patient every month Unused supplies must be returned at the end of the study Patients taking oral hydroxyurea to control their blood counts can continue it during the first month of imatinib mesylate treatment but must stop taking it from then on
After completing 2 months of therapy response to imatinib mesylate will be evaluated If the response is good treatment with imatinib mesylate alone will be continued If the response is not good the dose of imatinib mesylate will be increased to 8 tablets daily 4 in the morning and 4 in the evening or may be decreased to 3 tablets daily This will be based on how the drug is tolerated Treatment may be continued for up to one year or as long as it is judged best to control the leukemia
Patients will be asked to visit their doctor for a physical exam and vital signs The frequency of doctor visits will vary depending on physical condition
Blood tests about 2 teaspoons will be done once each year The blood samples will be used for routine lab tests A bone marrow sample will also be taken to check and measure cells related to the disease after 3 - 4 months then every 3-6 months in the first year If the initial bone marrow sample does not show disease repeated bone marrows will not be done
This is an investigational study Imatinib mesylate has been approved in CML for patients whose disease has not responded to interferon However this is an investigational study in patients with myeloproliferative diseases The FDA has authorized the use of imatinib mesylate in research A total of 145 patients will take part in this study All will be enrolled at MD 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