Trial of Decitabine in Patients With Acute Myeloid Leukemia

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Cytarabine or Supportive Care; Drug: Dacogen (decitabine) only

• Registration Number: NCT00260832
• Lead Sponsor: Eisai Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-01
• Study First Submitted QC: 2005-12-01
• Study First Posted: 2005-12-02
• Primary Completion: 2009-10
• Study Completion: 2010-12
• Results First Submitted: 2011-04-13
• Results First Submitted QC: 2011-08-16
• Status Verified: 2011-09
• Results First Posted: 2011-09-21
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Cytarabine or Supportive Care	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.)
B	Dacogen (decitabine) only	-

Primary Outcome Measures

Name	Time	Method
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.	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

Name	Time	Method
Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)	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.