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

Completed · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT00766116

Run by

University of California, San Diego

People needed

50

Starts

2005-07-01

Expected to finish

2014-09-26

Last updated by the study team

2019-02-18

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSD Moores Cancer Center — La Jolla, California, United States
• Stanford University — Stanford, California, United States
• Northside Hospital/BMTGA — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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