Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia
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The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.
A Dose Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) Given in Combination With Cytarabine in Relapsed or Refractory Patients and Alder De Novo Patients With Acute Myeloid Leukemia.
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Morphologic diagnosis of AML from bone marrow aspirate and biopsy
Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria
Age 18 years or older for relapsed or refractory patients for Phase I of this study
Patients with de novo AML of the M3 subtype
AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of > 2 months duration
AML secondary to exposure to chemotherapy or radiation