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

Participant Flow

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
Arm/Group Description	Decitabine 20 mg/m2 by vein over 1-...
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

Baseline Characteristics

Arm/Group Title		Decitabine + Gemtuzumab Ozogamicin
Arm/Group Description		Decitabine 20 mg/m2 by vein over 1-...
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
Baseline Analysis Population Description		[Not Specified]
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
United States		40

Outcome Measures

1.Primary Outcome


Title	Number of Participants With a Complete Response
Description	Complete Response (CR) was defined as normalization of peripheral bloo...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Decitabine + Gemtuzumab Ozogamicin
Arm/Group Description:	Decitabine 20 mg/m^2 by vein over 1...
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

Adverse Events

Time Frame	Three years, four months.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Decitabine + Gemtuzumab Ozogamicin
Arm/Group Description	Decitabine 20 mg/m2 by vein over 1-...
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	--/--
Serious Adverse Events 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)
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)

Limitations and Caveats

[Not Specified]

More Information

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

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