Status:
COMPLETED
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Celgene Corporation
Pfizer
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
PHASE2
Brief 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 aft...
Detailed Description
In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00766116
Start Date
July 1 2005
End Date
September 26 2014
Last Update
February 18 2019
Active Locations (3)
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1
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
2
Stanford University
Stanford, California, United States, 94305
3
Northside Hospital/BMTGA
Atlanta, Georgia, United States, 30342