Neoplasms

Blood and Lymph Conditions

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Wilms Tumor

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Wilms' Tumor

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.

OCV-501

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.

Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)

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).

Otsuka Pharmaceutical Co., Ltd.

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).

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 1 mg).

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 3 mg).

OCV-501 3 mg

Total

Age, Categorical

Sex: Female, Male

Japanese

Race/Ethnicity, Customized

Japan

Region of Enrollment

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.

Director of Clinical Trials

Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria

Overall Study

Spots Global Cancer Trial Database for Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial