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Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00968071
Recruitment Status : Completed
First Posted : August 28, 2009
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Sponsor:
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 71
Recruitment Details Recruitment Period: 2/19/2008 through 5/12/2009. All participants recruited at UT MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Decitabine + Gemtuzumab Ozogamicin
Hide Arm/Group Description Decitabine 20 mg/m^2 intravenously (IV) over an hour and half daily for 5 days plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
Period Title: Overall Study
Started 71
Completed 71
Not Completed 0
Arm/Group Title Decitabine Gemtuzumab Ozogamicin
Hide Arm/Group Description Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 71 participants
65
(26 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
31
  43.7%
Male
40
  56.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants
71
1.Primary Outcome
Title Number of Participants With Complete Response (CR)
Hide Description Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral anc >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.
Time Frame Up to 36 weeks
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 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
Overall Number of Participants Analyzed 71
Measure Type: Number
Unit of Measure: participants
3
Time Frame Four years, six months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Decitabine Gemtuzumab Ozogamicin
Hide Arm/Group Description Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV 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   15/71 (21.13%)    
General disorders   
Death  1  15/71 (21.13%)  15
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   44/71 (61.97%)    
Gastrointestinal disorders   
Hemorrhage  1  5/71 (7.04%)  5
Infections and infestations   
Infection other  1  22/71 (30.99%)  24
Febrile Neutropenia  1  24/71 (33.80%)  27
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 M.D./Associate Proffesor
Organization: The University of Texas M. D. 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: NCT00968071     History of Changes
Other Study ID Numbers: 2007-0882
First Submitted: August 26, 2009
First Posted: August 28, 2009
Results First Submitted: February 4, 2013
Results First Posted: March 8, 2013
Last Update Posted: March 8, 2013