Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386373
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2006-10-09
Brief Title:
Use and Tolerability of Imatinib Mesylate Gleevec in Leukemia Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Use and Tolerability of Imatinib Mesylate Gleevec in Patients With Philadelphia-Positive Chronic Myeloid or Acute Leukemia During the First 100 Days Following Bone Marrow or Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Primary Objective
1 To assess the safety and toxicity of imatinib mesylate when given to patients with Ph CML ALL or AML within the first 100 days following allogeneic bone marrow or stem cell transplantation
Secondary Objectives
1 To identify any clinically significant drug interactions with imatinib in the post-transplant setting
2 To develop specific monitoring parameters for imatinib use when utilized in the early post-BMT setting
3 To record one-year survival data in this patient cohort to assess any effect of early imatinib administration on this endpoint
1 To assess the safety and toxicity of imatinib mesylate when given to patients with Ph CML ALL or AML within the first 100 days following allogeneic bone marrow or stem cell transplantation
Secondary Objectives
1 To identify any clinically significant drug interactions with imatinib in the post-transplant setting
2 To develop specific monitoring parameters for imatinib use when utilized in the early post-BMT setting
3 To record one-year survival data in this patient cohort to assess any effect of early imatinib administration on this endpoint
Detailed Description:
Imatinib mesylate is an FDA-approved commercially available drug for patients with acute or chronic leukemias carrying the Philadelphia chromosome Women who are able to have children must have a negative blood pregnancy test before taking this drug
No earlier than three weeks after the bone marrow or stem cell transplant you will start taking imatinib mesylate by mouth You will take it once or twice a day until roughly 100 days following the transplant or until you are released from the Houston area by your M D Anderson physician Imatinib mesylate should be taken with a meal and a glass of water preferably in the morning
The dose will be gradually increased as long as you dont experience severe side effects If severe side effects occur imatinib will be stopped either temporarily or permanently
After about 100 days or after leaving Houston the medication may be continued at the discretion of the study doctor but the study will be considered completed
This is an investigational study A total of up to 40 patients will take part in this study All will be enrolled at M D Anderson The study is partially funded by the manufacturer of imatinib mesylate see below although the drug is not provided free of charge
No earlier than three weeks after the bone marrow or stem cell transplant you will start taking imatinib mesylate by mouth You will take it once or twice a day until roughly 100 days following the transplant or until you are released from the Houston area by your M D Anderson physician Imatinib mesylate should be taken with a meal and a glass of water preferably in the morning
The dose will be gradually increased as long as you dont experience severe side effects If severe side effects occur imatinib will be stopped either temporarily or permanently
After about 100 days or after leaving Houston the medication may be continued at the discretion of the study doctor but the study will be considered completed
This is an investigational study A total of up to 40 patients will take part in this study All will be enrolled at M D Anderson The study is partially funded by the manufacturer of imatinib mesylate see below although the drug is not provided free of charge
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