Trial of Decitabine in Patients With Acute Myeloid Leukemia

Eisai

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Cytarabine or Supportive Care; Drug: Dacogen (decitabine) only

Study type: Interventional

Funder types: Industry

Identifiers

NCT00260832

DACO-016

Details and patient eligibility

About

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.

Enrollment: 485 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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485 participants in 2 patient groups

A

Experimental group

Description:

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.)

Treatment:

Drug: Cytarabine or Supportive Care

B

Active Comparator group

Treatment:

Drug: Dacogen (decitabine) only