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A Study to Evaluate PT-523 in Patients With Refractory Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00129558
Recruitment Status : Withdrawn
First Posted : August 12, 2005
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: PT-523 for Injection Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of PT-523 in Patients With Refractory Leukemia
Study Start Date : July 2005
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129558

United States, California
USC, Kennth Norris Jr. Comprehensive Cancer Center
Los Angeles, California, United States, 90033-1048
UCLA School of Medicine
Los Angeles, California, United States, 90095-3075
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University School of Medicine Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Texas
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00129558     History of Changes
Other Study ID Numbers: HBS103
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Neoplasms by Histologic Type