Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML) - Full Text View

Purpose

The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: Decitabine	Phase II

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for:

5-Aza-2'-deoxycytidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase II Study of Decitabine For the Front-Line Treatment of Older Patients With Acute Myeloid Leukemia

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

Complete response. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	55
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Decitabine 20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.

Detailed Description:

(Note: This clinical trial was quality controlled by itself, since no protocol was available to Eisai Medical Research Inc.)

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment.
Ineligible to receive intensive chemotherapy for their disease.
Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.

Exclusion Criteria:

Received previous treatment for AML.
Previously received Vidaza.
Received any other investigational agents within 30 days of first dose of study drug.
Uncontrolled intercurrent illness.
Had radiotherapy within 14 days prior to study enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358644

Locations


United States, California
	City of Hope National Medical Center
	Duarte, California, United States, 91010
	UCLA Division of Hematology/Oncology
	Los Angeles, California, United States, 90095-1678

United States, Missouri
	Washington University School of Medicine
	St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Eisai Inc.

Investigators


Study Director:	Akhil Baranwal, MD	Eisai Medical Research Inc.

More Information

Official website of MGI PHARMA, Inc. This link exits the ClinicalTrials.gov site

Responsible Party:	Eisai Inc. ( Eisai Medical Services )
Study ID Numbers:	DACO-017
First Received:	July 31, 2006
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00358644
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Medical Research Inc.:

Acute Myeloid Leukemia

AML

Decitabine

Dacogen

MGI PHARMA, INC.

Study placed in the following topic categories:

Leukemia

Acute myelogenous leukemia

Decitabine

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Acute myelocytic leukemia

Additional relevant MeSH terms:

Antimetabolites

Neoplasms

Antimetabolites, Antineoplastic

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	Eisai Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00358644