Status:
WITHDRAWN
A Study to Evaluate PT-523 in Patients With Refractory Leukemia
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This Phase I/II, multi-centered, non-randomized, trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects...
Eligibility Criteria
Inclusion
- Relapsed/refractory leukemias including acute non-lymphocytic leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and chronic myelogenous leukemia in blastic phase (CML-BP) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (MDS) patients to include refractory anemia with excess blasts (RAEB) or excess blasts in transformation (RAEBT) and chronic myelomonocytic leukemia (CMML) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy.
- 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
- Known human immunodeficiency virus (HIV).
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00129558
Start Date
July 1 2005
End Date
September 1 2011
Last Update
December 4 2013
Active Locations (6)
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1
USC, Kennth Norris Jr. Comprehensive Cancer Center
Los Angeles, California, United States, 90033-1048
2
UCLA School of Medicine
Los Angeles, California, United States, 90095-3075
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Duke University Medical Center
Durham, North Carolina, United States, 27710