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Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous 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: NCT00053248
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : May 28, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: arsenic trioxide Drug: imatinib mesylate Phase 1 Phase 2

Detailed Description:


  • Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in patients with resistant chronic phase chronic myelogenous leukemia.
  • Determine potential dose-limiting toxic effects in patients treated with this regimen.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and then twice weekly. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-24 patients (at least 6 patients for phase I and at least 12 patients for phase II) will be accrued for this study .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study To Determine The Safety, Tolerability, And Anti-Leukemic Effects of Trisenox (Arsenic Trioxide) In Combination With Gleevec (STI571) In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase
Study Start Date : October 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Primary Outcome Measures :
  1. Satey and Tolerability
  2. Dose-limiting toxicity
  3. Pharmacokinetics

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Cytogenetically confirmed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting one of the following criteria:

    • Chronic phase

      • Less than 15% blasts in peripheral blood or marrow
      • Less than 30% blasts and promyelocytes in peripheral blood or marrow
      • Less than 20% basophils in blood or marrow
      • Platelet count at least 100,000/mm^3 (unless therapy related)
      • No progressive (increase of at least 10 cm in any 4 of the past 24 weeks) or existing (greater than 10 cm) splenomegaly
    • Complete hematologic response (CHR)

      • No immature myeloid cells in peripheral blood
      • No increased basophils in peripheral blood
      • WBC less than upper limit of normal (ULN)
      • Platelet count less than ULN
      • No major (less than 35% Ph+) or complete (0% Ph+) cytogenetic response after at least 6 months of imatinib mesylate

        • Loss of prior major cytogenetic response or failure to achieve major cytogenetic response



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • See Disease Characteristics


  • Bilirubin less than 1.5 times ULN
  • AST or ALT less than 2.5 times ULN


  • Creatinine less than 1.5 times ULN


  • No New York Heart Association grade III or IV congestive heart failure
  • No untreated symptomatic cardiac ischemia
  • No underlying cardiac arrhythmia, including but not limited to any of the following:

    • Conduction abnormality/atrioventricular heart block
    • Nodal/junctional arrhythmia/dysrhythmia
    • Sinus bradycardia or tachycardia
    • Supraventricular tachycardia
    • Ventricular arrhythmia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective barrier contraception during and for 3 months after study
  • Electrolyte levels (especially potassium and magnesium) normal (CHR patients)
  • No history of noncompliance that would preclude study participation
  • No other concurrent serious, uncontrolled medical condition
  • No grade 2 or greater neuropathy


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • More than 14 days since prior therapy except hydroxyurea, anagrelide hydrochloride, or imatinib mesylate
  • More than 28 days since prior investigational agents
  • No concurrent grapefruit or grapefruit juice

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): NCT00053248

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United States, California
UCLA Department of Medicine, Division of Hematology/Oncology
Los Angeles, California, United States, 90095
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Michael Mauro, MD OHSU Knight Cancer Institute
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Responsible Party: OHSU Knight Cancer Institute Identifier: NCT00053248    
Other Study ID Numbers: CDR0000269319
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: June 2010
Keywords provided by OHSU Knight Cancer Institute:
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Arsenic Trioxide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action