Use and Tolerability of Imatinib Mesylate (Gleevec) in Leukemia Patients
NCT ID: NCT00386373
Last Updated: 2012-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2003-08-31
2007-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 don't 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Imatinib Mesylate
Imatinib Mesylate
Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Imatinib Mesylate
Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. The disease must be beyond first chronic phase according to IBMTR criteria (i.e. accelerated phase, blastic phase, second chronic phase) at the time of transplant.
3. Patients with Ph(+) acute lymphocytic (or myeloid) leukemia.
4. Patients with diploid cytogenetics but molecular evidence of bcr-abl rearrangement are also eligible.
5. Age \>/= 16 years
6. Unsupported ANC at least 1500 and unsupported platelet count of at least 50K following BMT.
7. Patients may have received prior chemotherapy for their disease or be previously untreated.
8. Patients must have received an allogeneic bone marrow or stem cell transplant. Allogeneic transplant types may include matched sibling donors, mismatched related donors, or unrelated donors. All preparative regimens acceptable.
9. Signed informed consent
10. Zubrod status \</= 3
11. Adequate hepatic (bilirubin \</= 3 mg/dl, transaminases \< 4 x upper limit of normal) and renal function (serum creatinine \</= 3 mg/dl )
Exclusion Criteria
2. History of hypersensitivity to imatinib
3. Pregnant and lactating women
4. HIV positive
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paolo Anderlini, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
UT MD Anderson Cancer Center website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2003-0433
Identifier Type: -
Identifier Source: org_study_id