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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-111623 | Other Identifier | JAPIC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 0.3 mg |
|
| Cohort 2 | Experimental | 1 mg |
|
| Cohort 3 | Experimental | 3 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCV-501 | Drug | subcutaneously administered once a week, 4 times at the dose of 0.3 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Tokyo | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | subcutaneously administered once a week, 4 times at the dose of 0.3 mg |
| FG001 | Cohort 2 | subcutaneously administered once a week, 4 times at the dose of 1 mg |
| FG002 | Cohort 3 | subcutaneously administered once a week, 4 times at the dose of 3 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | subcutaneously administered once a week, 4 times at the dose of 0.3 mg |
| BG001 | Cohort 2 | subcutaneously administered once a week, 4 times at the dose of 1 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
| Posted | Number | participants | 4 Weeks |
|
Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | subcutaneously administered once a week, 4 times at the dose of 0.3 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OCV-501 |
| Drug |
subcutaneously administered once a week, 4 times at the dose of 1 mg |
|
| OCV-501 | Drug | subcutaneously administered once a week, 4 times at the dose of 3 mg |
|
| BG002 | Cohort 3 | subcutaneously administered once a week, 4 times at the dose of 3 mg |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Cohort 2 | subcutaneously administered once a week, 4 times at the dose of 1 mg |
| OG002 | Cohort 3 | subcutaneously administered once a week, 4 times at the dose of 3 mg |
|
|
| 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). | Posted | Number | participants | 4 weeks |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort 2 | subcutaneously administered once a week, 4 times at the dose of 1 mg | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Cohort 3 | subcutaneously administered once a week, 4 times at the dose of 3 mg | 0 | 3 | 0 | 3 | 3 | 3 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Injection site induration | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Injection site mass | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Protein urine present | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |