Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255346
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2005-11-16
Brief Title:
Dasatinib as Therapy for Myeloproliferative Disorders MPDs
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Therapy of Myeloid Metaplasia-Myelofibrosis Atypical Chronic Myeloid or Myelomonocytic Leukemia C-Kit Positive Acute Myeloid Leukemia AML or High-Risk Myelodysplastic Syndrome AML-MDS Hypereosinophilic Syndrome Polycythemia Vera and Mastocytosis With Dasatinib BMS-354825
Status:
COMPLETED
Status Verified Date:
2023-12
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 learn if dasatinib can help to control myeloproliferative disorders The safety and tolerability of dasatinib will also be studied
Detailed Description:
Dasatinib is an experimental anti-cancer drug that is designed to block the function of BCR-ABL which is the abnormal protein responsible for causing leukemia in some cells
If you are found to be eligible to take part in this study you will take dasatinib by mouth twice a day If you have mastocytosis you will take dasatinib by mouth once a day A treatment cycle will be defined as 4 weeks 28 days 7 days You will be instructed to take dasatinib in the morning between about 600 am-1000 am and in the evening between about 600 pm-1000 pm
Blood tests about 2 - 3 teaspoons will be done once a week for a month then once a month for 5 years then once every 6 months if your doctor thinks it is needed for the remainder of your treatment on this study A bone marrow biopsy will be done after 1-2 months of therapy to document response
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 authorized for use in research only A total of 145 patients will take part in this study All will be treated at MD Anderson
If you are found to be eligible to take part in this study you will take dasatinib by mouth twice a day If you have mastocytosis you will take dasatinib by mouth once a day A treatment cycle will be defined as 4 weeks 28 days 7 days You will be instructed to take dasatinib in the morning between about 600 am-1000 am and in the evening between about 600 pm-1000 pm
Blood tests about 2 - 3 teaspoons will be done once a week for a month then once a month for 5 years then once every 6 months if your doctor thinks it is needed for the remainder of your treatment on this study A bone marrow biopsy will be done after 1-2 months of therapy to document response
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 authorized for use in research only A total of 145 patients will take part in this study All will be treated at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01353 | REGISTRY | NCI CTRP | None |