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Completed

NCT Number: NCT00260832

Trial of Decitabine in Patients With 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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cytarabine or Supportive Care

Drug

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.)

Dacogen (decitabine) only

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Dec 2, 2005
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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