A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
18 Years
90 Years
Both
Acute Myeloid Leukemia
Trial Information
A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
In Phase I the Maximum Tolerated Dose will be the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicity
Outcome Time Frame:
approximately 4 years
Safety Issue:
Yes
Authority:
United States: Institutional Review Board
Study ID:
090516
NCT ID:
NCT00766116
Start Date:
July 2005
Completion Date:
May 2014
Related Keywords:
- Acute Myeloid Leukemia
- AML
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Stanford University | Stanford, California 94305 |
| Northside Hospital/BMTGA | Atlanta, Georgia 30342 |
