Clinical trial NCT00386373: Use and Tolerability of Imatinib Mesylate (Gleevec) in Leukemia Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Keywords: Chronic Myeloid Leukemia
CML
ALL
AML
Leukemia
Imatinib Mesylate
Gleevec
Philadelphia-Positive
Bone marrow transplant
BMT
Stem cell transplant
SCT
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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: 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 negative blood pregnancy test before taking this drug

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.

Eligibility 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 \</= 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

Primary outcomes:
measure: Toxicity Rate
timeFrame: 100 Days and 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Paolo Anderlini, MD
role: PRINCIPAL_INVESTIGATOR
References: