Trial of Decitabine in Patients With Acute Myeloid Leukemia - Full Text View

Purpose

The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: Cytarabine or Supportive Care Drug: Dacogen (decitabine) only	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Resource links provided by NLM:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Cytarabine Decitabine

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML. [ Time Frame: The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first. ] [ Designated as safety issue: No ]
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.

Secondary Outcome Measures:

Comparison of Complete Remission Rates Between Arm A and Arm B [ Time Frame: Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available. No stated duration of response required for complete remission classification ] [ Designated as safety issue: No ]
Morphologic complete remission (CR) plus CR without platelet recovery (CRp) rate

Enrollment:	485
Study Start Date:	November 2005
Study Completion Date:	December 2010
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.)	Drug: Cytarabine or Supportive Care Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one invervention.)
Active Comparator: B	Drug: Dacogen (decitabine) only 20mg/m^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops. Other Name: decitabine

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have diagnosed acute myeloid leukemia.
Must have a life expectancy of at least 12 weeks.
Must sign informed consent.

Exclusion Criteria:

Must not have acute promyelocytic leukemia (M3 classification)
Must not have any other active systemic malignancies.
Must not have inaspirable bone marrow.
Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
Must not have chronic respiratory disease that requires continuous oxygen use.
Must not have received any experimental drug within 4 weeks before randomization.
Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
Must not have known HIV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260832

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Locations

United States, California

Los Angeles, California, United States
United States, Florida

Fort Myers, Florida, United States, 33901

Gainesville, Florida, United States, 32610

Hollywood, Florida, United States

Lakeland, Florida, United States, 33805

Miami, Florida, United States

Orange Park, Florida, United States, 32073
United States, Illinois

Chicaco, Illinois, United States, 60612

Highland Park, Illinois, United States
United States, Indiana

Terre Haute, Indiana, United States, 47804
United States, Iowa

Sioux City, Iowa, United States, 51101
United States, Kansas

Wichita, Kansas, United States, 67214
United States, Louisiana

Baton Rouge, Louisiana, United States

Shreveport, Louisiana, United States
United States, Massachusetts

Boston, Massachusetts, United States

Springfield, Massachusetts, United States, 01107
United States, Michigan

Gross Pte Woods, Michigan, United States, 48236

Kalamazoo, Michigan, United States, 49048
United States, New Jersey

Neptune, New Jersey, United States
United States, New York

New York, New York, United States

Valhalla, New York, United States, 10595
United States, North Carolina

Durham, North Carolina, United States, 27710
United States, Ohio

Canton, Ohio, United States, 44710

Cincinnati, Ohio, United States, 45267
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina

Charleston, South Carolina, United States, 29406

Greenville, South Carolina, United States
United States, South Dakota

Sioux Falls, South Dakota, United States, 57105
United States, Tennessee

Knoxville, Tennessee, United States, 37920

Nashville, Tennessee, United States
United States, Texas

Austin, Texas, United States, 78705

Galveston, Texas, United States, 77555

Houston, Texas, United States, 77030

Temple, Texas, United States
United States, Wisconsin

Eau Claire, Wisconsin, United States

Glendale, Wisconsin, United States, 53212

Milwaukee, Wisconsin, United States
Australia, New South Wales

Darlinghurst, New South Wales, Australia

St. Leonards, New South Wales, Australia, 2065
Australia, Queensland

South Brisbane, Queensland, Australia, 4101
Australia, South Australia

Adelaide, South Australia, Australia
Australia, Victoria

East Melbourne, Victoria, Australia, 3002

Parkville, Victoria, Australia, 3052
Australia, Western Australia

Perth, Western Australia, Australia, 6000
Canada, Newfoundland and Labrador

St. John's, Newfoundland and Labrador, Canada, AiB 3V6
Canada, Nova Scotia

Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario

Toronto, Ontario, Canada, M4N 3M5
Croatia

Rijeka, Croatia

Zagreb, Croatia

Zalaegerszeg, Croatia
Czech Republic

Brno, Czech Republic, 62500

Ceske Budejovice, Czech Republic

Plzen, Czech Republic

Praha 2, Czech Republic, 128 08
France

Bobigny, France, 93009

Creteil Cedex, France

Lille, France, 59037

Limoges Cedex, France

Lyon, France, 69437

Nantes, France, 44000

Pessac, France
Hungary

Budapest, Hungary

Gyor, Hungary, 9024

Gyula, Hungary, 5700

Szeged, Hungary

Szombathely, Hungary
Mexico

Mexico City, Mexico
Poland

Gdansk, Poland

Krakow, Poland

Lodz, Poland, 93-510

Lublin, Poland, 20-081

Poznan, Poland

Warszawa, Poland

Wroclaw, Poland, 50-367
Romania

Bucharest, Romania

Cluj-Napoca, Romania, 400124

Targu-Mures, Romania, 540042
Russian Federation

Arkhangelsk, Russian Federation

Astrakhan, Russian Federation

Barnaul, Russian Federation

Izhevsk, Russian Federation

Kirov, Russian Federation

Kransnodar, Russian Federation

Moscow, Russian Federation

Novosibirsk, Russian Federation

Petrozavodsk, Russian Federation

Ryazan, Russian Federation

Samara, Russian Federation

Saratov, Russian Federation

St. Petersburg, Russian Federation

Tyumen, Russian Federation

Volgograd, Russian Federation
Serbia

Belgrade, Serbia, 11000

Nis, Serbia

Novi Sad, Serbia, 21000
Spain

Badalona-Barcelona, Spain, 08916

Barcelona, Spain, 08035

Girona, Spain

Madrid, Spain, 28006

Palma de Mallorca, Spain, 07014

Pamplona, Spain, 31008

Salamanca, Spain

Valencia, Spain
Taiwan

Changhua, Taiwan

Kaohsiung, Taiwan

Tainan, Taiwan, 70403

Taipei, Taiwan, 10449
United Kingdom

Sutton, United Kingdom

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Eisai Medical Services

Eisai Global Clinical Development

More Information

No publications provided

Responsible Party:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00260832 History of Changes
Other Study ID Numbers:	DACO-016
Study First Received:	December 1, 2005
Results First Received:	April 13, 2011
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Inc.:

Acute Myeloid Leukemia
Dacogen
Decitabine
Poor or intermediate-risk cytogenetics

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013