Acute Myeloid Leukemia
Conditions
Keywords
Acute myeloid leukemia, WT1
Brief summary
The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.
Interventions
DRUGOCV-501
subcutaneously administered once a week, 4 times at the dose of 0.3 mg
Sponsors
Otsuka Pharmaceutical Co., Ltd.
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
Key Inclusion Criteria: * Patients with acute myeloid leukemia including patients with secondary leukemia. However, the patients with MDS apparently evolved itno AML and patients with AML accompanied by t(15;17)(q22;q12),(PML/RARalpha) , should be excluded. * Patients who achieved the first complete remission after the induction regimen and finished a standard consolidation therapy. * Age: ≥ 60years of age(at the time of signature of the informed consent form) * Sex: Male and Female * Patients who are capable of giving informed consent * Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR. * Patients must be one of the following HLA DRB1 types: HLA-DRB1\*01:01, \*04:05, \*15:01, \*15:02, \*08:03 and \*09:01. Key
Exclusion criteria
* Patients who are scheduled for a bone marrow transplantation * Patients who were administered exceeded acceptable therapeutic dose of immunosuppressants and adrenal cortical steroids. * Patients with uncontrollable active infectious diseases * Patients with autoimmune diseases (including Hashimoto's disease, idiopathic thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of active autoimmune diseases * Immunocompetent patients * Patients with a complication of interstitial pneumonia or with a medical history of interstitial pneumonia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Dose Limiting Toxicities | 4 Weeks | Dose limiting toxicity (DLT) was defined as any of the following adverse events occurring by Day 29 (7 days after the last investigational medicinal product \[IMP\] administration) of this trial for which a causal relationship to the IMP could not be ruled out. Severity of the adverse events was evaluated in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ver. 4.0. Blood toxicity did not include hematology parameters of laboratory tests. * Non-blood toxicities ≥ Grade 3, excluding cases of anorexia, nausea, vomiting, diarrhea, and constipation where it is possible to continue the clinical trial by use of supportive therapy * Blood toxicities ≥ Grade 4, although febrile neutropenia ≥ Grade 3 will be counted as DLT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Based on the Response Evaluation Criteria by the International Working Group | 4 weeks | A case will be designated as relapse if any of the following occur. Reappearance of leukemic blast cells in the peripheral blood or ≥5% blast cells in the bone marrow after complete remission (morphologic relapse). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 subcutaneously administered once a week, 4 times at the dose of 0.3 mg | 3 |
| Cohort 2 subcutaneously administered once a week, 4 times at the dose of 1 mg | 3 |
| Cohort 3 subcutaneously administered once a week, 4 times at the dose of 3 mg | 3 |
| Total | 9 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Cohort 3 | 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 | 3 / 3 | 3 / 3 | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Occurrence of Dose Limiting Toxicities
Dose limiting toxicity (DLT) was defined as any of the following adverse events occurring by Day 29 (7 days after the last investigational medicinal product \[IMP\] administration) of this trial for which a causal relationship to the IMP could not be ruled out. Severity of the adverse events was evaluated in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ver. 4.0. Blood toxicity did not include hematology parameters of laboratory tests. * Non-blood toxicities ≥ Grade 3, excluding cases of anorexia, nausea, vomiting, diarrhea, and constipation where it is possible to continue the clinical trial by use of supportive therapy * Blood toxicities ≥ Grade 4, although febrile neutropenia ≥ Grade 3 will be counted as DLT.
Time frame: 4 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Occurrence of Dose Limiting Toxicities | 0 participants |
| Cohort 2 | Occurrence of Dose Limiting Toxicities | 0 participants |
| Cohort 3 | Occurrence of Dose Limiting Toxicities | 0 participants |
Secondary
Recurrence Based on the Response Evaluation Criteria by the International Working Group
A case will be designated as relapse if any of the following occur. Reappearance of leukemic blast cells in the peripheral blood or ≥5% blast cells in the bone marrow after complete remission (morphologic relapse).
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Recurrence Based on the Response Evaluation Criteria by the International Working Group | 0 participants |
| Cohort 2 | Recurrence Based on the Response Evaluation Criteria by the International Working Group | 0 participants |
| Cohort 3 | Recurrence Based on the Response Evaluation Criteria by the International Working Group | 0 participants |