Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

• Status: Completed
• Trial end date: 2014-09-26
• Target enrollment: 0
• Participant gender: All

Summary

This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: Celgene Corporation; Pfizer
• Treatments: Azacitidine; Gemtuzumab

Criteria

Inclusion Criteria:

• Diagnosis of Relapsed AML

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy > 3 months

• ≥ 18 years old

• Previously untreated for current AML relapse

• Adequate organ function

• Written informed consent

Exclusion Criteria:

• Pregnant or breast-feeding women

• Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days

• Currently receiving another investigational drug

• Currently receiving other anti-cancer agents

• Uncontrolled infection

• HIV positive

• Received previous therapy with either Mylotarg or 5-azacitidine