Trial of Decitabine in Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00260832
First received: December 1, 2005
Last updated: September 20, 2011
Last verified: September 2011
  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:


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:

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

Exclusion Criteria:

  1. Must not have acute promyelocytic leukemia (M3 classification)
  2. Must not have any other active systemic malignancies.
  3. Must not have inaspirable bone marrow.
  4. Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
  5. Must not have chronic respiratory disease that requires continuous oxygen use.
  6. Must not have received any experimental drug within 4 weeks before randomization.
  7. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
  8. Must not have known HIV.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
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 by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Cytarabine
Decitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014