Trial of Decitabine in Patients With Acute Myeloid Leukemia

The purpose of this study is to compare the results in patients (65 years and older) who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are randomly assigned to receive either decitabine or another supportive care medication of the patient’s choice with the physician’s advice.

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

Conditions

Acute Myeloid Leukemia

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Overall survival in patients 65 years or older who have newly diagnosed de novo or secondary AML.

Study Start

November 2005; Expected completion: December 2008

Eligibility & Criteria

• Ages Eligible for Study: 65 Years and above
• Genders Eligible for Study: Both

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 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

Total Enrolment

480

Contact Details

Royal Adelaide Hospital, South Australia, Australia; Recruiting

• Ian Lewis, MD: 08 8222 36 19, ian.lewis@imvs.sa.gov.au

Royal North Shore Hospital, St. Leonards, New South Wales, 2065, Australia; Recruiting

• Chris Arthur: +612 9926 7118

Mater Adult Hospital, South Brisbane, Queensland, 4101, Australia; Recruiting

• Kerry Taylor +617 3840 8111

Royal Melbourne Hospital, Parkville, Victoria, 3052, Australia; Recruiting

• Jeff Szer +613 9342 7396

Royal Perth Hospital, Perth, Western Australia, 6000, Australia; Recruiting

• Richard Hermann +618 9224 1165

MGI Pharma Website