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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
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Interventions Drug: Decitabine
Drug: Gemtuzumab ozogamicin
Enrollment 43
Recruitment Details Recruitment Period: 04/02/09 through 6/23/2010. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details Of the forty-three participants registered only forty participants received treatment and were evaluable for toxicity and response.
Arm/Group Title Decitabine + Gemtuzumab Ozogamicin
Hide Arm/Group Description Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title Decitabine + Gemtuzumab Ozogamicin
Hide Arm/Group Description Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
74
(42 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
17
  42.5%
Male
23
  57.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Number of Participants With a Complete Response
Hide Description 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).
Time Frame Day 14 of first cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Decitabine + Gemtuzumab Ozogamicin
Hide Arm/Group Description:
Decitabine 20 mg/m^2 by vein over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m^2 by vein on day 5.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
10
Time Frame Three years, four months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Decitabine + Gemtuzumab Ozogamicin
Hide Arm/Group Description Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
All-Cause Mortality
Decitabine + Gemtuzumab Ozogamicin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Decitabine + Gemtuzumab Ozogamicin
Affected / at Risk (%) # Events
Total   1/40 (2.50%)    
Metabolism and nutrition disorders   
Elevated Amylase/Lipase  1  1/40 (2.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Decitabine + Gemtuzumab Ozogamicin
Affected / at Risk (%) # Events
Total   22/40 (55.00%)    
Gastrointestinal disorders   
Hemorhage  1  2/40 (5.00%)  2
Mucositis  1  2/40 (5.00%)  2
Infections and infestations   
Febrile Neutropenia  1  20/40 (50.00%)  20
Infection  1  4/40 (10.00%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gautam Borthakur, MD/Associate Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-563-1586
EMail: eharriso@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00882102     History of Changes
Other Study ID Numbers: 2008-0288
First Submitted: April 15, 2009
First Posted: April 16, 2009
Results First Submitted: June 6, 2013
Results First Posted: August 9, 2013
Last Update Posted: September 13, 2013