Overview

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

Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Imatinib Mesylate
Criteria
Inclusion Criteria:

1. 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).

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
11. Adequate hepatic (bilirubin and renal function (serum creatinine
Exclusion Criteria:

1. Grade III/IV cardiac problems as defined by the NYHAC

2. History of hypersensitivity to imatinib

3. Pregnant and lactating women

4. HIV positive