Trial of Decitabine in Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260832
• Other study ID #: DACO-016
• Status: Completed
• Phase: Phase 3
• Start date: November 2005
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: December 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

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.)
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Croatia,  Czechia,  France,  Hungary,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)	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)