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

This study has been completed.
Sponsor:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00244829
First received: October 25, 2005
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Leukemia
Drug: imatinib mesylate
Procedure: adjuvant therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Safety at 90 days following transplant [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • BCR/ABL transcript load at 90 days following transplant [ Designated as safety issue: No ]
  • Standard management of progressive minimal residual disease at 90 days following transplant [ Designated as safety issue: No ]
  • Survival at 1 year [ Designated as safety issue: No ]

Study Start Date: January 2004
Study Completion Date: August 2007
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 leukemia.

Secondary

  • 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00244829

Locations
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
Investigators
Study Chair: Paul Carpenter, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00244829     History of Changes
Other Study ID Numbers: 1867.00, FHCRC-1867.00, CDR0000355118
Study First Received: October 25, 2005
Last Updated: November 28, 2011
Health Authority: United States: Federal Government

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:
Leukemia
Philadelphia Chromosome
Abnormal Karyotype
Neoplasms by Histologic Type
Neoplasms
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014