Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413478
Status:
TERMINATED
Last Update Posted:
2015-06-30
First Post:
2006-12-15
Brief Title:
5-Azacytidine Azacytidine Vidaza in Chronic Lymphocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of 5-Azacytidine Azacytidine Vidaza in Chronic Lymphocytic Leukemia
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia CLL Richters transformation and T-cell prolymphocytic leukemia T-PLL
Detailed Description:
Azacytidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes By blocking the bad genes the tumor-fighting genes may be able to work better
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have blood drawn about 3 teaspoons to check your kidney and liver function routine blood tests You may have a bone marrow aspiration performed if you have not had one in recent weeks To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle Women who are able to have children must have a negative urine pregnancy test
If you agree to take part in this study you will receive azacytidine by subcutaneous just under the skin injection every day for 7 days This course of treatment will be repeated every 3-8 weeks depending on the results of your routine blood tests
Your doctor may increase or decrease your dose of azacytidine depending on if you experience any side effects You will continue to receive treatment on this study unless the disease gets worse or you experience any intolerable side effects If the disease gets worse or you experience any intolerable side effects you will be taken off this study
This is an investigational study This is an investigational study Azacytidine has been approved by the FDA for the treatment of myelodysplastic syndrome Up to 37 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 screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have blood drawn about 3 teaspoons to check your kidney and liver function routine blood tests You may have a bone marrow aspiration performed if you have not had one in recent weeks To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle Women who are able to have children must have a negative urine pregnancy test
If you agree to take part in this study you will receive azacytidine by subcutaneous just under the skin injection every day for 7 days This course of treatment will be repeated every 3-8 weeks depending on the results of your routine blood tests
Your doctor may increase or decrease your dose of azacytidine depending on if you experience any side effects You will continue to receive treatment on this study unless the disease gets worse or you experience any intolerable side effects If the disease gets worse or you experience any intolerable side effects you will be taken off this study
This is an investigational study This is an investigational study Azacytidine has been approved by the FDA for the treatment of myelodysplastic syndrome Up to 37 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-00552 | REGISTRY | NCI CTRP | None |