A Study to Evaluate PT-523 in Patients With Refractory Leukemia
A Phase I/II Study of PT-523 in Patients With Refractory Leukemia
1 other identifier
interventional
N/A
1 country
6
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 with refractory leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2005
Typical duration for phase_1 leukemia
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 10, 2005
CompletedFirst Posted
Study publicly available on registry
August 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 4, 2013
December 1, 2013
6.2 years
August 10, 2005
December 2, 2013
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
USC, Kennth Norris Jr. Comprehensive Cancer Center
Los Angeles, California, 90033-1048, United States
UCLA School of Medicine
Los Angeles, California, 90095-3075, United States
University of Chicago
Chicago, Illinois, 60637, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University School of Medicine Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1082, United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2005
First Posted
August 12, 2005
Study Start
July 1, 2005
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
December 4, 2013
Record last verified: 2013-12