Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT00037596
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2002-05-17
• Study First Submitted QC: 2002-05-17
• Study First Posted: 2002-05-20
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified