Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)
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|ClinicalTrials.gov Identifier: NCT00882102|
Recruitment Status : Completed
First Posted : April 16, 2009
Results First Posted : August 9, 2013
Last Update Posted : September 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia Myelodysplastic Syndrome||Drug: Decitabine Drug: Gemtuzumab ozogamicin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Decitabine + Gemtuzumab Ozogamicin
Decitabine 20 mg/m^2 by vein (IV) over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m^2 by vein on day 5.
Decitabine 20 mg/m^2 IV over 1-1/2 hours daily for 5 days.
Other Name: Dacogen®
Drug: Gemtuzumab ozogamicin
Gemtuzumab ozogamicin 3 mg/m^2 IV on day 5.
Other Name: Mylotarg®
- Number of Participants With a Complete Response [ Time Frame: Day 14 of first cycle ]Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Approximately Day 14 of the first cycle of 4 - 8 week cycle, a bone marrow aspirate was performed to check the status of the disease using International Working Group (IWG) criteria for acute myelogenous leukemia (AML) and myelofibrosis (MF).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882102
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gautam Borthakur, M.D.||M.D. Anderson Cancer Center|