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CompletedNCT00386373Updated Aug 1, 2012

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

An interventional study of Imatinib Mesylate in Leukemia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2012-08-01.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Leukemia

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Keywords

  • Chronic Myeloid Leukemia
  • CML
  • ALL
  • AML
  • Leukemia
  • Imatinib Mesylate
  • Gleevec
  • Philadelphia-Positive
  • Bone marrow transplant
  • BMT
  • Stem cell transplant
  • SCT
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 10 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Imatinib Mesylate

    Drug: Imatinib Mesylate

Interventions

  • DrugImatinib Mesylate

    Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).

    Also known as: Gleevec, Imatinib, STI571, NSC-716051

06

What researchers measure

Primary outcomes

  1. Toxicity Rate

    Time frame: 100 Days and 1 Year

07

Study locations

1 site
  • U.T.M.D. Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00386373
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Oct 11, 2006
Start date
Aug 2003
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Aug 1, 2012

Study contacts

Paolo Anderlini, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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