drugset / Trial / NCT00044733

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

NCT00044733

Phase 2 Completed 38 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
Open-label

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.

Timeline

Start
2000-03
Primary completion
Completion
2004-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemtuzumab Ozogamicin Monoclonal antibody 9 mg/m2