NCT00037583

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

A Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (go) Given in Combination With Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de Novo Patients With Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Gemtuzumab Ozogamicin

Timeline

• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2002-05-20
• Last updated: 2009-08-21