Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Conditions
Keywords
Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Dacogen, Decitabine
Brief summary
The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the DACO-018 study.
Detailed description
The objectives of this trial are: * To generate additional information about the overall safety profile, * To generate safety information of hepatically or renally impaired patients, as appropriate, and * To generate safety information when patients are also taking concomitant medications and/or therapies without trial restrictions when decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with MDS or AML (≥ 30% blasts). The purpose of this open-label, expanded-access trial is to provide decitabine to patients with AML or MDS who have completed participation per protocol in the DACO-018 study and for whom continuation of treatment with decitabine is indicated, per the opinion of the investigator. In order to continue treatment with decitabine, at a minimum, there must be no disease progression while the patient was participating in the DACO-018 trial and during the period after the patient discontinued from the DACO-018 study and before entering this trial. Patients must enroll in this trial within 8 weeks of discontinuing from the DACO-018 study and not have received any other chemotherapy for their disease during this interim period. Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
Interventions
DRUGDecitabine
Decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML; ≥ 30% blasts).
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must sign an Institutional Review Board (IRB) -approved informed consent form, indicating his/her awareness of the investigational nature of decitabine and its potential hazards prior to initiation of any study-specific procedures or treatment. 2. Must have had one of the following: MDS (de novo or secondary) fitting any of the recognized French-American-British classifications OR chronic myelomonocytic leukemia (with WBC \<12,000/μL) AND an International Prognostic Scoring System score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of study entry OR AML (≥ 30 % bone marrow blasts), except M3 or acute promyelocytic leukemia. 3. Must be age 18 years or older. 4. Must have completed participation per protocol in the MGI PHARMA DACO-018 decitabine trial. 5. Must enroll in this trial no more than 8 weeks after discontinuation from the MGI PHARMA DACO-018 trial. 6. Must have recovered from all toxic effects of all prior therapy.
Exclusion criteria
1. Must not have any other active malignancy, other than basal or squamous cell skin carcinoma. 2. Must not have received in the period after discontinuation from DACO-018 and enrollment into this trial any other chemotherapy agent, including investigational agents, for their disease. 3. Must not have evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial, at the discretion of the principal investigator. 4. Must not be pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subjects With Adverse Events | 3 months | Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m\^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (\< 30% blasts) or AML (\> 30% blasts). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decitabine Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 5 |
| Overall Study | Progressive Disease | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Decitabine |
|---|---|
| Age Continuous | 68.5 years STANDARD_DEVIATION 11.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 6 / 10 |
Outcome results
Primary
The Number of Subjects With Adverse Events
Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m\^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (\< 30% blasts) or AML (\> 30% blasts).
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decitabine | The Number of Subjects With Adverse Events | 10 participants |