Use and Tolerability of Imatinib Mesylate (Gleevec) in Leukemia Patients

Completed · Not applicable

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT00386373

Run by

M.D. Anderson Cancer Center

People needed

10

Starts

2003-08-01

Expected to finish

2007-10-01

Last updated by the study team

2012-08-01

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 )

You may not qualify if…

• Grade III/IV cardiac problems as defined by the NYHAC
• History of hypersensitivity to imatinib
• Pregnant and lactating women
• HIV positive

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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