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Use and Tolerability of Imatinib Mesylate (GleevecĀ®) in Patients With Philadelphia-Positive Chronic Myeloid or Acute Leukemia During the First 100 Days Following Bone Marrow or Stem Cell Transplantation


N/A
16 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Use and Tolerability of Imatinib Mesylate (GleevecĀ®) in Patients With Philadelphia-Positive Chronic Myeloid or Acute Leukemia During the First 100 Days Following Bone Marrow or Stem Cell Transplantation


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity Rate

Outcome Time Frame:

100 Days and 1 Year

Safety Issue:

Yes

Principal Investigator

Paolo Anderlini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2003-0433

NCT ID:

NCT00386373

Start Date:

August 2003

Completion Date:

October 2007

Related Keywords:

  • Leukemia
  • Chronic Myeloid Leukemia
  • CML
  • ALL
  • AML
  • Leukemia
  • Imatinib Mesylate
  • Gleevec
  • Philadelphia-Positive
  • Bone marrow transplant
  • BMT
  • Stem cell transplant
  • SCT
  • Leukemia

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030