Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050531
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2002-12-12
Brief Title:
High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia CML
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Randomized Trial of Therapy of Early Phase Chronic Myelogenous Leukemia With High-Dose Imatinib Mesylate Gleevec Alone or in Combination With Peg-Alpha Interferon PEG-Intron and Sargramostim GM-CSF
Status:
COMPLETED
Status Verified Date:
2015-08
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 giving PEG-Alpha Interferon PEG-Intron and Sargramostim GM-CSF to patients receiving treatment with high dose Gleevec imatinib mesylate is more effective in treating CML in chronic phase than therapy with imatinib mesylate alone
Detailed Description:
Imatinib mesylate is a drug that blocks a protein that is responsible for the development of CML PEG-Intron is a natural substance made by the cells of the immune system and helps to control CML GM-CSF is a hormone that helps to stimulate the production of white blood cells
During the study you will take 400 mg of imatinib mesylate by mouth 2 times a day 800 mg a day total Imatinib mesylate should be taken each morning and evening with a large glass of water You may be given a pill diary to write down when day and time you take the drug You may also write in the diary any side effects you may experience You may bring the diary any unused tablets and empty bottles of imatinib mesylate with you to every visit to the study doctor Any unused supplies must be returned at the end of the study
After completing 6 months of imatinib mesylate therapy you will be randomly assigned as in the toss of a coin to one of two groups Patients in the first group will be given PEG-Intron and GM-CSF in addition to imatinib mesylate therapy Patients in the other group will continue taking only imatinib mesylate
If you are assigned to the group that will receive PEG-Intron and GM-CSF you will continue taking imatinib mesylate In addition PEG-Intron will be given as an injection under the skin once a week Sargramostim will be given as an injection under the skin 3 times a week You andor your family members can be taught to give these injections
Every 1-2 weeks during the first 4 weeks of the study you will have around 2 teaspoons of blood drawn for routine blood tests and to measure the amount of imatinib in your blood The blood tests will then be repeated every 6 to 8 weeks or more often if your doctor feels it is necessary for as long as you are on the study A bone marrow sample will also be taken every 3 months for the first year and then every 4 to 6 months for as long as you are on the study to check on the status of the disease
You will be asked to visit the doctor for a physical exam and to have vital signs measured These visits will be scheduled at least every 3 months while you are on the study The visits may be scheduled more often depending on the status of the disease
Update February 2012
Blood test are recommended 2 times per year Your doctor will discuss with you how often you should have blood tests Bone marrow will be done if your doctor thinks it is needed to check the disease You must return to MD Anderson at least once every year You may not need a bone marrow test every visit but you will have blood drawn to measure the amount of disease you have
Treatment in both groups may be continued for up to 7-10 years or as long as the doctor feels is necessary to control the leukemia
If the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
This is an investigational study All of the drugs used in this study are FDA approved and commercially available However their use in this study is investigational A total of 98 patients will take part in this study All will be enrolled at MD Anderson
During the study you will take 400 mg of imatinib mesylate by mouth 2 times a day 800 mg a day total Imatinib mesylate should be taken each morning and evening with a large glass of water You may be given a pill diary to write down when day and time you take the drug You may also write in the diary any side effects you may experience You may bring the diary any unused tablets and empty bottles of imatinib mesylate with you to every visit to the study doctor Any unused supplies must be returned at the end of the study
After completing 6 months of imatinib mesylate therapy you will be randomly assigned as in the toss of a coin to one of two groups Patients in the first group will be given PEG-Intron and GM-CSF in addition to imatinib mesylate therapy Patients in the other group will continue taking only imatinib mesylate
If you are assigned to the group that will receive PEG-Intron and GM-CSF you will continue taking imatinib mesylate In addition PEG-Intron will be given as an injection under the skin once a week Sargramostim will be given as an injection under the skin 3 times a week You andor your family members can be taught to give these injections
Every 1-2 weeks during the first 4 weeks of the study you will have around 2 teaspoons of blood drawn for routine blood tests and to measure the amount of imatinib in your blood The blood tests will then be repeated every 6 to 8 weeks or more often if your doctor feels it is necessary for as long as you are on the study A bone marrow sample will also be taken every 3 months for the first year and then every 4 to 6 months for as long as you are on the study to check on the status of the disease
You will be asked to visit the doctor for a physical exam and to have vital signs measured These visits will be scheduled at least every 3 months while you are on the study The visits may be scheduled more often depending on the status of the disease
Update February 2012
Blood test are recommended 2 times per year Your doctor will discuss with you how often you should have blood tests Bone marrow will be done if your doctor thinks it is needed to check the disease You must return to MD Anderson at least once every year You may not need a bone marrow test every visit but you will have blood drawn to measure the amount of disease you have
Treatment in both groups may be continued for up to 7-10 years or as long as the doctor feels is necessary to control the leukemia
If the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
This is an investigational study All of the drugs used in this study are FDA approved and commercially available However their use in this study is investigational A total of 98 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01295 | REGISTRY | NCI CTRP | None |