Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT00037583
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-05-17
• Study First Submitted QC: 2002-05-17
• Study First Posted: 2002-05-20
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
• Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
• Phase II will only allow enrollment of younger de novo AML

Exclusion Criteria

• AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
• De novo patients with M3 AML
• AML secondary to exposure to chemotherapy or radiation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified