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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-111646 | Other Identifier | JAPIC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCV-501 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCV-501 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Treatment period (from the first IMP administration until the time of discontinuation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Tokyo | Japan |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The demographics and other baseline characteristics of subjects enrolled in this trial were the same as those in Trial 311-10-001 as the trial was an extension trial from the preceding Trial 311-10-001 and the data obtained before the start of investigational medicinal product (IMP) administration in Trial 311-10-001 were used as the baseline data in this trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | OCV-501 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 | 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). | Posted | Number | participants | Treatment period (from the first IMP administration until the time of discontinuation) |
|
Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
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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 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ichthyosis | Congenital, familial and genetic 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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|
| Other than specified |
|
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).
| BG002 | 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). |
| 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 |
|
| 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). |
| OG002 | 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). |
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| 2 |
| 3 |
| EG001 | 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). | 0 | 3 | 2 | 3 | 3 | 3 |
| EG002 | 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). | 0 | 3 | 3 | 3 | 3 | 3 |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Ear pruritus | Ear and labyrinth disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Dry eye | Eye disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Hypermetropia | Eye disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Injection site reaction | 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 erythema | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Injection site discolouration | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Administration site reaction | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Injection site anaesthesia | 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 |
|
| Injection site pruritus | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 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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| Abscess | Infections and infestations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue 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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| Post herpetic neuralgia | Nervous system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Ver. 14.0 | Non-systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |