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

December 2, 2013 updated by: Spectrum Pharmaceuticals, Inc

A Phase I/II Study of PT-523 in Patients With Refractory Leukemia

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

August 10, 2005

First Submitted That Met QC Criteria

August 11, 2005

First Posted (Estimate)

August 12, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBS103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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