Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)

This study has been completed.

Study NCT00067808 Information provided by M.D. Anderson Cancer Center

First Received on August 27, 2003. Last Updated on June 3, 2011 History of Changes

Results First Received: September 25, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia
Intervention:	Drug: Decitabine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period 6/4/03 - 5/18/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment of 128 patients: 1 patient withdrew consent prior to treatment; 3 did not meet eligibility requirement for a total of 124 evaluable patients.

Reporting Groups

	Description
Decitabine 10 mg/m2 IV	10 mg/m2 by vein (IV) over 1 hour daily for 10 days
Decitabine 20 mg/m2 IV	20 mg/m2 IV over 1 hour daily for 5 days
Decitabine 20 mg/m2 SQ	20 mg/m2 subcutaneous (SQ) daily for 5 days

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Decitabine 10 mg/m2 IV	10 mg/m2 by vein (IV) over 1 hour daily for 10 days
Decitabine 20 mg/m2 IV	20 mg/m2 IV over 1 hour daily for 5 days
Decitabine 20 mg/m2 SQ	20 mg/m2 subcutaneous (SQ) daily for 5 days

Baseline Measures

	Decitabine 10 mg/m2 IV	Decitabine 20 mg/m2 IV	Decitabine 20 mg/m2 SQ	Total
Number of Participants [units: participants]	17	93	14	124
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	7	45	7	59
>=65 years	10	48	7	65
Age [units: years] Median ( Full Range )	67 ( 44 to 90 )	65 ( 37 to 83 )	64 ( 51 to 79 )	65 ( 37 to 90 )
Gender [units: participants]
Female	3	33	4	40
Male	14	60	10	84
Region of Enrollment [units: participants]
United States	17	93	14	124

Outcome Measures

1. Primary:

Participant Responses [ Time Frame: Response to treatment after 8 weeks of therapy ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Hagop Kantarjian, MD / Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713-792-7026

No publications provided

Responsible Party:	Hagop Kantarjian, MD / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00067808 History of Changes
Other Study ID Numbers:	ID03-0180
Study First Received:	August 27, 2003
Results First Received:	September 25, 2009
Last Updated:	June 3, 2011
Health Authority:	United States: Food and Drug Administration