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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00386373
First received: October 9, 2006
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.

Condition Intervention
Leukemia
Drug: Imatinib Mesylate

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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Toxicity Rate [ Time Frame: 100 Days and 1 Year ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: August 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imatinib Mesylate Drug: Imatinib Mesylate
Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).
Other Names:
  • Gleevec
  • Imatinib
  • STI571
  • NSC-716051

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386373

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Paolo Anderlini, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00386373     History of Changes
Other Study ID Numbers: 2003-0433
Study First Received: October 9, 2006
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Chronic Myeloid Leukemia
CML
ALL
AML
Leukemia
Imatinib Mesylate
Gleevec
Philadelphia-Positive
Bone marrow transplant
BMT
Stem cell transplant
SCT

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014