Acute Myeloid Leukemia
Conditions
Keywords
Acute myeloid leukemia, WT1
Brief summary
The purpose of this study is to assess the safety of OCV-501 in patients with AML who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.
Interventions
DRUGOCV-501
1. Before the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the dose in the study 311-10-001. 2. After the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the recommended dose.
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study. * Patients who are capable of giving informed consent
Exclusion criteria
* Patients failed to discontinue the Study 311-10-001 even though patients met the discontinuation criteria. * Patients who have participated in any other clinical trials , excluding the Study 311-10-001).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria | Treatment period (from the first IMP administration until the time of discontinuation) | Bone marrow samples were taken by bone marrow aspiration, and the percentage of bone marrow blasts was calculated. The result was assessed according to the International Working Group Response Evaluation Criteria where a case was designated as relapse if any of the following occurred: reappearance of leukemic blasts in the peripheral blood or ≥ 5% blasts in the bone marrow after complete response (morphologic relapse). |
Countries
Japan
Participant flow
Recruitment details
This trial was an extension trial from the preceding Trial 311-10-001. Subjects who had undergone the observations, examinations, and evaluations which were stipulated for Trial 311-10-001 and who met all the inclusion criteria and did not fall under any of the exclusion criteria for this trial were selected for this trial.
Participants by arm
| Arm | Count |
|---|---|
| OCV-501 0.3mg OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg). | 3 |
| OCV-501 1 mg OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg). | 3 |
| OCV-501 3 mg OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg). | 3 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Exacerbation of primary disease | 2 | 2 | 2 |
| Overall Study | Other than specified | 1 | 0 | 0 |
| Overall Study | Study drug administration difficult | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | OCV-501 0.3mg | OCV-501 1 mg | OCV-501 3 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Japanese | 3 Participants | 3 Participants | 3 Participants | 9 Participants |
| Region of Enrollment Japan | 3 Participants | 3 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 2 / 3 | 3 / 3 | 3 / 3 |
| serious Total, serious adverse events | 3 / 3 | 2 / 3 | 3 / 3 |
Outcome results
Primary
Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria
Bone marrow samples were taken by bone marrow aspiration, and the percentage of bone marrow blasts was calculated. The result was assessed according to the International Working Group Response Evaluation Criteria where a case was designated as relapse if any of the following occurred: reappearance of leukemic blasts in the peripheral blood or ≥ 5% blasts in the bone marrow after complete response (morphologic relapse).
Time frame: Treatment period (from the first IMP administration until the time of discontinuation)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OCV-501 0.3mg | Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria | 2 participants |
| OCV-501 1 mg | Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria | 2 participants |
| OCV-501 3 mg | Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria | 2 participants |