NCT00017589

Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia

Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Genta Incorporated · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.

Detailed description

OBJECTIVES: * Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin. * Determine the overall response rate and duration of response of patients treated with this regimen. * Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study within 1 year.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	oblimersen sodium
DRUG	gemtuzumab ozogamicin

Timeline

• Start date: 2000-12-01
• Completion: 2006-05-01
• First posted: 2003-01-27
• Last updated: 2014-01-06

Locations

1 site across 1 country: United States