View Clinical Trial (Medical Research Study)
A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
| City: |
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Atlanta |
| State: |
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Georgia |
| Zip Code: |
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30342 |
| Conditions: |
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Acute Myeloid Leukemia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Diagnosis of Relapsed AML
- 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
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| NCT ID: |
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NCT00766116 |
| Primary Contact: |
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Edward D Ball, MD
Phone: 858-822-6600
Email: tball@ucsd.edu
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| Backup Contact: |
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Email: scorringham@ucsd.edu
Sue Corringham, RN
Phone: 858-822-6387
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| Location Contact: |
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Atlanta, Georgia 30342
United States
Asad Bashey, MD
Phone: 404-255-1930
Email: abashey@bmtga.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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