Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

Wyeth

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Gemtuzumab Ozogamicin; Drug: cytarabine.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00037596

0903B1-205

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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