NCT00129558WithdrawnPhase 1
A Phase I/II Study of PT-523 in Patients With Refractory Leukemia
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Locations
- 6
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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 -
- •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.
Investigators
Study Sites (6)
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