Leukemia Clinical Trial
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
Verified date | July 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 </= 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: 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | U.T.M.D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity Rate | 100 Days and 1 Year | Yes |
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