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

subcutaneously administered once a week, 4 times at the dose of 0.3 mg

OCV-501

subcutaneously administered once a week, 4 times at the dose of 1 mg

subcutaneously administered once a week, 4 times at the dose of 3 mg

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.

A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients

A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia

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.

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).

Otsuka Pharmaceutical Co., Ltd.

Cohort 1

Cohort 2

Cohort 3

Total

Age, Categorical

Sex: Female, Male

Japanese

Race/Ethnicity, Customized

Japan

Region of Enrollment

Director of Clinical Trials

Occurrence of Dose Limiting Toxicities

Recurrence Based on the Response Evaluation Criteria by the International Working Group

Overall Study

Spots Global Cancer Trial Database for A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial