Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant

Phase 2

Completed

• Conditions: Acute Myelogenous Leukemia

• Registration Number: NCT00044733
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9 mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms of the number of patients attaining a complete (CR) or morphological (CRp) remission.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2002-09-04
• Study First Submitted QC: 2002-09-05
• Study First Posted: 2002-09-06
• Study Completion: 2004-09
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-17
• Last Update Posted: 2006-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified