Leukemia
Conditions
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.
Interventions
Sponsors
Spectrum Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Countries
United States
Outcome results
None listed