Acute Myeloid Leukemia
Conditions
Keywords
OCV-501, Acute Myeloid Leukemia, Antigen specific cancer immunotherapeutic
Brief summary
To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.
Interventions
DRUGOCV-501
DRUGPlacebo
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with AML who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course). * Patients who are 60 years or older. * Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee.
Exclusion criteria
* Patients who have acute promyelocytic leukemia (APL) with t(15;17) (q22;q12), (PML/RARA) karyotype abnormalities, and other variant types. * Patients who are scheduled for hematopoietic stem cell transplantation. * Patients who have received drugs potentially affecting the immune system within 4 weeks before starting IMP administration or who may receive such drugs after start of the trial. * Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial. * Patients who are HIV antibody positive, HBV-DNA positive or have unrecovered chronic hepatitis C with positive HCV antibody. * Patients who have cirrhosis. * Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival | 2 years (treatment period) | Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years (treatment period) | Subjects were surveyed for survival by the date of cutoff. The cutoff date was set as the date after 728 days (2 years) from the day that the last subject started IMP administration. |
Countries
Japan, South Korea, Taiwan
Participant flow
Pre-assignment details
Of the 134 subjects randomized in this trial, one subject who was randomized but did not receive the investigational medicinal product (IMP) was excluded from all analysis data sets.
Participants by arm
| Arm | Count |
|---|---|
| OCV-501 3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward. | 68 |
| Placebo Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward. | 65 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Relapse of AML | 39 | 37 |
| Overall Study | Subject found to be ineligible for the trial after registration | 1 | 0 |
| Overall Study | Use of prohibited concomitant drug or therapy | 2 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Total | OCV-501 | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 96 Participants | 49 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 19 Participants | 18 Participants |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 5.89 | 68.3 years STANDARD_DEVIATION 5.61 | 68.6 years STANDARD_DEVIATION 6.2 |
| Race/Ethnicity, Customized Asian | 133 Participants | 68 Participants | 65 Participants |
| Region of Enrollment Japan | 105 Participants | 52 Participants | 53 Participants |
| Region of Enrollment South Korea | 18 Participants | 9 Participants | 9 Participants |
| Region of Enrollment Taiwan | 10 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Female | 52 Participants | 22 Participants | 30 Participants |
| Sex: Female, Male Male | 81 Participants | 46 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 68 | 1 / 65 |
| other Total, other adverse events | 67 / 68 | 59 / 65 |
| serious Total, serious adverse events | 7 / 68 | 7 / 65 |
Outcome results
Primary
Disease-Free Survival
Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date.
Time frame: 2 years (treatment period)
Population: FAS: all subjects who received the IMP at least once and from whom data on at least 1 efficacy endpoint were obtained after the start of IMP administration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OCV-501 | Disease-Free Survival | 40.9 percentage of participants |
| Placebo | Disease-Free Survival | 41.4 percentage of participants |
Secondary
Overall Survival
Subjects were surveyed for survival by the date of cutoff. The cutoff date was set as the date after 728 days (2 years) from the day that the last subject started IMP administration.
Time frame: 2 years (treatment period)
Population: FAS: all subjects who received the IMP at least once and from whom data on at least 1 efficacy endpoint were obtained after the start of IMP administration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OCV-501 | Overall Survival | 60.3 percentage of participants |
| Placebo | Overall Survival | 58.5 percentage of participants |