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Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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/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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (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 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

Sites / Locations

  • MD Anderson Cancer Center at University of Texas

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
November 12, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00023881
Brief Title
Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
Official Title
Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
July 2, 2001 (Actual)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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/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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Cortes, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
MD Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

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