Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of California, San Diego
With
Celgene Corporation
Pfizer
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 times over two weeks
In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.
A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
