Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

Basic Trial Information

Objectives

1. 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.
2. Assess the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• 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/mm³) 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• 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

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Other:

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 18 weeks

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance greater than 60 mL/min

Other:

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

Expected Enrollment

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

Outline

Patients receive bortezomib 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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Jorge Cortes, MD, Protocol chair		Ph: 713-794-5783; 800-392-1611 Email: jcortes@mdanderson.org

Registry Information
Official Title		Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase
Trial Start Date		2001-07-02
Registered in ClinicalTrials.gov		NCT00023881
Date Submitted to PDQ		2001-07-10
Information Last Verified		2004-11-08
NCI Grant/Contract Number		P30-CA16672, U01-CA62461

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