Trial of Decitabine in Patients With Acute Myeloid Leukemia

August 29, 2019 updated by: Eisai Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia
      • St. Leonards, New South Wales, Australia, 2065
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
    • South Australia
      • Adelaide, South Australia, Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
      • Parkville, Victoria, Australia, 3052
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, AiB 3V6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
  • Croatia
      • Rijeka, Croatia
      • Zagreb, Croatia
      • Zalaegerszeg, Croatia
  • Czechia
      • Brno, Czechia, 62500
      • Ceske Budejovice, Czechia
      • Plzen, Czechia
      • Praha 2, Czechia, 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
  • United States
    • California
      • Los Angeles, California, 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
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Highland Park, Illinois, United States
    • Indiana
      • Terre Haute, Indiana, United States, 47804
    • Iowa
      • Sioux City, Iowa, United States, 51101
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Springfield, Massachusetts, United States, 01107
    • Michigan
      • Grosse Pointe Woods, Michigan, United States, 48236
      • Kalamazoo, Michigan, United States, 49048
    • New Jersey
      • Neptune, New Jersey, United States
    • New York
      • New York, New York, United States
      • Valhalla, New York, United States, 10595
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Canton, Ohio, United States, 44710
      • Cincinnati, Ohio, United States, 45267
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
    • South Carolina
      • Charleston, South Carolina, United States, 29406
      • Greenville, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States, 78705
      • Galveston, Texas, United States, 77555
      • Houston, Texas, United States, 77030
      • Temple, Texas, United States
    • Wisconsin
      • Eau Claire, Wisconsin, United States
      • Glendale, Wisconsin, United States, 53212
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • decitabine
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 intervention.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)
Time Frame: Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)
Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (>)1,000 per microliter (/mcL), platelet count of >=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count >=100,000/mcL.
Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: Eisai Medical Services, Eisai Global Clinical Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 1, 2005

First Submitted That Met QC Criteria

December 1, 2005

First Posted (Estimate)

December 2, 2005

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DACO-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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