Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415909
Status:
TERMINATED
Last Update Posted:
2014-06-30
First Post:
2006-12-22
Brief Title:
TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Proof of Concept Study of TALL-104 MHC Non-Restricted Cytotoxic T-Cell Line and Imatinib Mesylate Gleevec in Chronic Myelogenous Leukemia in Chronic Phase
Status:
TERMINATED
Status Verified Date:
2014-05
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:
Objectives
To determine the response rate and duration of response with combination of TALL-104 cells and imatinib mesylate IM therapy in patients with chronic myelogenous leukemia in chronic phase that have not achieved or have lost adequate response to IM
To determine the toxicity of the combination of TALL-104 cells and IM therapy in this patient population
To determine the response rate and duration of response with combination of TALL-104 cells and imatinib mesylate IM therapy in patients with chronic myelogenous leukemia in chronic phase that have not achieved or have lost adequate response to IM
To determine the toxicity of the combination of TALL-104 cells and IM therapy in this patient population
Detailed Description:
Imatinib mesylate is designed to block the enzyme that is believed to be responsible for starting the type of leukemia patient has TALL-104 cells are cells of the immune system that have been obtained from a patient with leukemia and then processed in the laboratory to try to make them able to kill leukemia cells
If found to be eligible to take part in this study patient will continue receiving imatinib mesylate by mouth at the same schedule and dose patient had been receiving before entering the study Patient will receive TALL-104 cells through a needle in their vein over 1 hour on Days 1-4 and then again on Days 7 10 14 17 and 21 of the cycle The cycle will last 28 days
Blood about 1 tablespoon will be drawn every week for the first 4 weeks then every 2-4 weeks for 2 months then every 4-6 weeks until 6 months and then every 3-6 months for routine tests and to check for any effect on organs
Patient will have follow-up visits at 1 month 3 months 6 months and at least annually for 2 years and then at least every 5 years from then on for the rest of your life Blood about 1 teaspoon will be drawn to check the status of the disease An additional 1 tablespoon will also be collected and stored to be analyzed in case unexpected side effects occur after receiving therapy If patient experiences certain side effects more blood may need to be drawn and more tests performed based on the side effects experienced
Up to 20 patients will take part in this study All will be enrolled at M D Anderson
If found to be eligible to take part in this study patient will continue receiving imatinib mesylate by mouth at the same schedule and dose patient had been receiving before entering the study Patient will receive TALL-104 cells through a needle in their vein over 1 hour on Days 1-4 and then again on Days 7 10 14 17 and 21 of the cycle The cycle will last 28 days
Blood about 1 tablespoon will be drawn every week for the first 4 weeks then every 2-4 weeks for 2 months then every 4-6 weeks until 6 months and then every 3-6 months for routine tests and to check for any effect on organs
Patient will have follow-up visits at 1 month 3 months 6 months and at least annually for 2 years and then at least every 5 years from then on for the rest of your life Blood about 1 teaspoon will be drawn to check the status of the disease An additional 1 tablespoon will also be collected and stored to be analyzed in case unexpected side effects occur after receiving therapy If patient experiences certain side effects more blood may need to be drawn and more tests performed based on the side effects experienced
Up to 20 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