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Status:

COMPLETED

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

Lead Sponsor:

Fred Hutchinson Cancer Center

Conditions:

Leukemia

Eligibility:

All Genders

Phase:

PHASE1

PHASE2

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 rec...

Detailed Description

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

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Performance status
  • Not specified
  • Life expectancy
  • At least 2 months
  • Hematopoietic
  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,200/mm\^3 (use of filgrastim \[G-CSF\] allowed)
  • Hepatic
  • Not specified
  • Renal
  • Not specified
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Disease Characteristics

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    August 1 2007

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00244829

    Start Date

    January 1 2004

    End Date

    August 1 2007

    Last Update

    November 30 2011

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    City of Hope Comprehensive Cancer Center

    Duarte, California, United States, 91010-3000

    2

    Fred Hutchinson Cancer Research Center

    Seattle, Washington, United States, 98109-1024