Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 2/20/2019 |
| Start Date: | July 2005 |
| End Date: | September 26, 2014 |
A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
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.
the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that
has come back after treatment.
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.
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.
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
We found this trial at
3
sites
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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