Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).

This study has been completed.

Study NCT00088218 Information provided by M.D. Anderson Cancer Center

First Received on July 22, 2004. Last Updated on April 14, 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: Diagnostic
Conditions:	Acute Myeloid Leukemia Myelodysplastic Syndrome
Interventions:	Drug: Clofarabine Drug: Ara-C

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period 7/21/04 - 2/15/08; 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
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Reporting Groups

	Description
Clofarabine	Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
Clofarabine Plus Ara-C	Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.

Participant Flow: Overall Study

	Clofarabine	Clofarabine Plus Ara-C
STARTED	16	79
COMPLETED	16	79
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Clofarabine	Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
Clofarabine Plus Ara-C	Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.

Baseline Measures

	Clofarabine	Clofarabine Plus Ara-C	Total
Number of Participants [units: participants]	16	79	95
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	1	12	13
>=65 years	15	67	82
Age [units: years] Median ( Full Range )	72 ( 60 to 83 )	70 ( 60 to 82 )	70 ( 60 to 83 )
Gender [units: participants]
Female	4	34	38
Male	12	45	57
Region of Enrollment [units: participants]
United States	16	79	95

Outcome Measures

1. Primary:

Number of Participants With Response [ Time Frame: Every 2 to 8 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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: Stefan Fader, M.D./Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713/745-4613
e-mail: eharriso@mdanderson.org

No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Faderl S, Ravandi F, Huang X, Garcia-Manero G, Ferrajoli A, Estrov Z, Borthakur G, Verstovsek S, Thomas DA, Kwari M, Kantarjian HM. A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. Blood. 2008 Sep 1;112(5):1638-45. Epub 2008 Jun 18.

Responsible Party:	Stefan Fader, M.D./Associate Professor, The University of Texas M. D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00088218 History of Changes
Other Study ID Numbers:	2004-0183
Study First Received:	July 22, 2004
Results First Received:	September 25, 2009
Last Updated:	April 14, 2011
Health Authority:	United States: Food and Drug Administration