Bortezomib 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: NCT00023881
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 10, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have chronic myelogenous leukemia in chronic or accelerated phase.

Condition or disease Intervention/treatment Phase
Leukemia Drug: bortezomib Phase 2

Detailed Description:


  • Determine the efficacy of bortezomib, in terms of response rate, duration of response, and survival of patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic or accelerated phase.
  • Assess the toxicity of this drug in these patients.

OUTLINE: Patients receive bortezomib intravenous (IV) over 3-5 seconds twice weekly on weeks 1-2. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 5-30 patients will be accrued for this study within 15-30 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase
Study Start Date : July 2001
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

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


  • Diagnosis of Philadelphia (Ph) chromosome-positive chronic myelogenous leukemia (CML) in chronic or accelerated phase, defined as having any of the following:

    • Peripheral blood (PB) or bone marrow (BM) blasts at least 10% but less than 30%
    • PB or BM blasts and promyelocytes at least 20%
    • PB or BM basophils at least 20%
    • Progressive splenomegaly (at least 10 cm confirmed twice at least 4 weeks apart or 50% increase in splenomegaly over 4 weeks)
    • Clonal evolution defined as the presence of additional cytogenetic abnormalities other than the Ph chromosome
    • Thrombocytopenia (platelet count less than 100,000/mm^3) unrelated to therapy
    • Hemoglobin less than 7 g/dL unrelated to therapy or bleeding
  • Failed prior treatment with imatinib mesylate or intolerant, unable, or unwilling to receive it
  • Ineligible for higher-priority or higher-efficacy regimens or protocols
  • No blastic phase CML



  • 18 and over

Performance status:

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

  • At least 18 weeks


  • See Disease Characteristics


  • Bilirubin no greater than 1.5 mg/dL


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No other concurrent illness that would preclude study entry
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • No more than 2 prior cytotoxic regimens in addition to imatinib mesylate and/or hydroxyurea
  • At least 4 weeks since prior chemotherapy and recovered
  • Concurrent hydroxyurea and/or anagrelide allowed during first 2 courses

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered


  • Not specified


  • See Disease Characteristics
  • See Chemotherapy
  • At least 24 hours since prior imatinib mesylate
  • No other concurrent investigational agents

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): NCT00023881

United States, Texas
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Jorge Cortes, MD M.D. Anderson Cancer Center

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00023881     History of Changes
Other Study ID Numbers: CDR0000068872
DM00-274 ( Other Identifier: UT MD Anderson Cancer Center )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012

Keywords provided by M.D. Anderson Cancer Center:
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Proteasome Inhibitors
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action