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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
485

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2005

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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