Status:
COMPLETED
Use and Tolerability of Imatinib Mesylate (Gleevec) in Leukemia Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Eligibility:
All Genders
16+ years
Phase:
NA
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 ce...
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 neg...
Eligibility Criteria
Inclusion
- Patients with Ph(+) CML and/or CML with bcr-abl rearrangement and diploid cytogenetics not eligible for protocols of higher priority (e.g. ID02-901, DM99-081, DM97-206, etc).
- 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.
- Patients with Ph(+) acute lymphocytic (or myeloid) leukemia.
- Patients with diploid cytogenetics but molecular evidence of bcr-abl rearrangement are also eligible.
- Age \>/= 16 years
- Unsupported ANC at least 1500 and unsupported platelet count of at least 50K following BMT.
- Patients may have received prior chemotherapy for their disease or be previously untreated.
- 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.
- Signed informed consent
- Zubrod status \</= 3
- Adequate hepatic (bilirubin \</= 3 mg/dl, transaminases \< 4 x upper limit of normal) and renal function (serum creatinine \</= 3 mg/dl )
Exclusion
- Grade III/IV cardiac problems as defined by the NYHAC
- History of hypersensitivity to imatinib
- Pregnant and lactating women
- HIV positive
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00386373
Start Date
August 1 2003
End Date
October 1 2007
Last Update
August 1 2012
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030