NCT00023881

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Jul 2001

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

3.7 years

First QC Date

September 13, 2001

Last Update Submit

November 12, 2018

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiachronic myelogenous leukemia, BCR-ABL1 positive

Interventions

bortezomibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jorge Cortes, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

July 2, 2001

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(1)