Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129740
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2005-08-11
Brief Title:
Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia CML
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Therapy of Early Chronic Phase Chronic Myelogenous Leukemia CML With Oral Nilotinib
Status:
COMPLETED
Status Verified Date:
2019-09
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 an experimental agent AMN107 nilotinib can help to control CML in chronic phase The safety of this experimental agent will also be studied
Detailed Description:
Nilotinib is a drug that is designed to block a protein that is responsible for the development of CML
If you are found to be eligible to take part in this study you will take 2-4 nilotinib capsules or tablets by mouth 2 times a day 4-8 capsules or tablets a day total every day at least 8 hours apart Nilotinib should be taken each morning and evening with a large glass of water The study medication will be given to you every 3 - 12 months You will also be given a pill diary to write down when day and time you take the drug You will also write in the diary any side effects you may experience You should bring the diary any unused capsules or tablets and empty containers of nilotinib with you to every visit to the study doctor Any unused supplies must be returned at the end of the study
Every 1-4 weeks during the first 4 weeks of the study you will have around 2 teaspoons of blood drawn for routine blood tests The blood tests will then be repeated every 4-8 weeks or more often if your doctor feels it is necessary until you have been on study for 6 months then every 3 to 6 months for another 18 months After that you may have the blood tests repeated as often as the doctor thinks it is needed A bone marrow sample will also be taken every 3-4 months for the first year and then every 6-12 months in the 2nd year then every 2-3 years for as long as you are on the study to check on the status of the disease Additionally blood about ½ tablespoon will be drawn or a bone marrow sample will be collected every 3-4 months for the first year and then every 6-12 months until 2 years and then about one time a year for as long as you are on the study to check on the status of the disease However if you are in complete remission after Year 2 your doctor will decide when you will have a bone marrow aspiration But you will still have blood drawn about ½ tablespoon every 1 - 3 years to check the status of your disease An ECG will be repeated around Day 5 and then at about 6 weeks and about 3 months
You will be asked to visit the doctor for a physical exam and to have vital signs measured periodically These visits will be scheduled at least every 3 to 4 months the first year After the first year the study staff will recommend that you have physical exams once every year The visits may be scheduled more often depending on the status of the disease
Treatment may be continued for up to 8-10 years or as long as the doctor feels it 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 Nilotinib is FDA approved A total of 150 patients will take part in this study All will be enrolled at MD Anderson
If you are found to be eligible to take part in this study you will take 2-4 nilotinib capsules or tablets by mouth 2 times a day 4-8 capsules or tablets a day total every day at least 8 hours apart Nilotinib should be taken each morning and evening with a large glass of water The study medication will be given to you every 3 - 12 months You will also be given a pill diary to write down when day and time you take the drug You will also write in the diary any side effects you may experience You should bring the diary any unused capsules or tablets and empty containers of nilotinib with you to every visit to the study doctor Any unused supplies must be returned at the end of the study
Every 1-4 weeks during the first 4 weeks of the study you will have around 2 teaspoons of blood drawn for routine blood tests The blood tests will then be repeated every 4-8 weeks or more often if your doctor feels it is necessary until you have been on study for 6 months then every 3 to 6 months for another 18 months After that you may have the blood tests repeated as often as the doctor thinks it is needed A bone marrow sample will also be taken every 3-4 months for the first year and then every 6-12 months in the 2nd year then every 2-3 years for as long as you are on the study to check on the status of the disease Additionally blood about ½ tablespoon will be drawn or a bone marrow sample will be collected every 3-4 months for the first year and then every 6-12 months until 2 years and then about one time a year for as long as you are on the study to check on the status of the disease However if you are in complete remission after Year 2 your doctor will decide when you will have a bone marrow aspiration But you will still have blood drawn about ½ tablespoon every 1 - 3 years to check the status of your disease An ECG will be repeated around Day 5 and then at about 6 weeks and about 3 months
You will be asked to visit the doctor for a physical exam and to have vital signs measured periodically These visits will be scheduled at least every 3 to 4 months the first year After the first year the study staff will recommend that you have physical exams once every year The visits may be scheduled more often depending on the status of the disease
Treatment may be continued for up to 8-10 years or as long as the doctor feels it 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 Nilotinib is FDA approved A total of 150 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?:
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-2012-01313 | REGISTRY | NCI CTRP | None |