A Study to Evaluate PT-523 in Patients With Refractory Leukemia
NCT ID: NCT00129558
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2005-07-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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PT-523 for Injection
Eligibility Criteria
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Inclusion Criteria
* Only patients with refractory ALL or CML in lymphoid blastic phase are eligible for phase II.
* ECOG performance status 0 - 2.
* Adequate organ function and bone marrow reserve.
* At least 4 weeks must have elapsed from the time of major surgery.
* Use of appropriate contraceptive method.
* Signed patient informed consent.
Exclusion Criteria
* Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
* Patients receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine.
* Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
18 Years
ALL
No
Sponsors
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Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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USC, Kennth Norris Jr. Comprehensive Cancer Center
Los Angeles, California, United States
UCLA School of Medicine
Los Angeles, California, United States
University of Chicago
Chicago, Illinois, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University School of Medicine Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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Hana Biosciences, Inc. is a South San Francisco, CA-based biopharmaceutical company that acquires, develops, and commercializes innovative products to advance cancer care.
Other Identifiers
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HBS103
Identifier Type: -
Identifier Source: org_study_id