Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00244829
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : November 30, 2011
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia.

PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: imatinib mesylate Procedure: adjuvant therapy Phase 1 Phase 2

Detailed Description:



  • Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with high-risk Philadelphia chromosome-positive leukemia.


  • Determine the bcr/abl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment.
  • Determine the 1-year survival of patients treated with this drug.

OUTLINE: This is an open-label, pilot, multicenter study.

Beginning within 14-30 days after allogeneic stem cell transplantation, patients receive oral imatinib mesylate once daily until 1 year after transplantation. Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias
Study Start Date : January 2004
Actual Study Completion Date : August 2007

Primary Outcome Measures :
  1. Safety at 90 days following transplant

Secondary Outcome Measures :
  1. BCR/ABL transcript load at 90 days following transplant
  2. Standard management of progressive minimal residual disease at 90 days following transplant
  3. Survival at 1 year

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of 1 of the following:

    • Acute lymphoblastic leukemia or chronic myeloid leukemia (CML) characterized by p^190 and/or p^210 bcr/abl gene rearrangement
    • Accelerated or blastic phase CML
    • CML in second or greater chronic phase
  • No imatinib mesylate-resistant leukemia
  • Planned allogeneic hematopoietic stem cell transplantation

    • Availability of an appropriately matched related or unrelated donor
    • Autologous or nonmyeloablative transplantation is not allowed
  • None of the following within 4 days after the date of neutrophil engraftment*:

    • More than 5% marrow blasts
    • Circulating peripheral blood leukemic blasts
    • Aberrant antigen expression on marrow myeloblasts ≥ 1% by multidimensional flow cytometric assay
    • Presence of bcr/abl in > 5% of marrow interphase nuclei by fluorescent in situ hybridization
    • More than 1 of 20 Philadelphia chromosome-positive marrow metaphases
    • CNS involvement by leukemia NOTE: *The date of neutrophil engraftment is defined as the second consecutive day at which the peripheral blood absolute neutrophil count exceeds 500/mm3


Performance status

  • Not specified

Life expectancy

  • At least 2 months


  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,200/mm^3 (use of filgrastim [G-CSF] allowed)


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known imatinib mesylate hypersensitivity
  • No other disease that severely limits life expectancy


Biologic therapy

  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00244829

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Study Chair: Paul Carpenter, MD Fred Hutchinson Cancer Research Center Identifier: NCT00244829     History of Changes
Other Study ID Numbers: 1867.00
CDR0000355118 ( Registry Identifier: PDQ )
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: November 30, 2011
Last Verified: November 2011

Keywords provided by Fred Hutchinson Cancer Research Center:
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
childhood chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission

Additional relevant MeSH terms:
Philadelphia Chromosome
Neoplasms by Histologic Type
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action