Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, AML, Decitabine, Dacogen, MGI PHARMA, INC.
Brief summary
The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).
Interventions
DRUGDecitabine
20 mg/m\^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.
Sponsors
Eisai Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment. 2. Ineligible to receive intensive chemotherapy for their disease. 3. Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.
Exclusion criteria
1. Received previous treatment for AML. 2. Previously received Vidaza. 3. Received any other investigational agents within 30 days of first dose of study drug. 4. Uncontrolled intercurrent illness. 5. Had radiotherapy within 14 days prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response = Morphologic Complete Remission (mCR) | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decitabine 20 mg/m2 Intravenous Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Death | 11 |
| Overall Study | Patient not eligible for study | 1 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Progressive Disease | 21 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Decitabine 20 mg/m2 Intravenous |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 48 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age Continuous | 73.0 years STANDARD_DEVIATION 6.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 55 / 55 |
| serious Total, serious adverse events | 40 / 55 |
Outcome results
Primary
Complete Response = Morphologic Complete Remission (mCR)
Time frame: 1 year
Population: Intent-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decitabine 20 mg/m2 Intravenous | Complete Response = Morphologic Complete Remission (mCR) | 13 Participants |
95% CI: [13.2, 37]