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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

HBS103

NCT ID:

NCT00129558

Start Date:

July 2005

Completion Date:

September 2011

Related Keywords:

  • Leukemia
  • Leukemia

Name

Location

UCLA School of MedicineLos Angeles, California  900121973
Duke University Medical CenterDurham, North Carolina  27710
University of Texas M. D. Anderson Cancer CenterHouston, Texas  77030
University of ChicagoChicago, Illinois  60637
USC, Kennth Norris Jr. Comprehensive Cancer CenterLos Angeles, California  90033-1048
Wake Forest University School of Medicine Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1082