UMIN ID: UMIN000045499
Registered date:16/09/2021
Follow up study of Phase II clinical trial of OCV-501
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | acute myeloid leukemia |
| Date of first enrollment | 2021/09/16 |
| Target sample size | 80 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | 5-year disease free survival; OCV-501 group vs. placebo group |
|---|---|
| Secondary Outcome | 5-year overall survival; OCV-501 group vs. placebo group Specific immunological responses to WT-1 and prognosis Level of WT1 mRNA and prognosis |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Cases showing a manifestation of non-participation in this study 2) Cases who the principal investigator deems inappropriate as a research subject |
Related Information
| Primary Sponsor | National Hospital Organization Nagoya Medical Center IRB |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | International Institute of Cancer Immunology, Inc. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tomoki Naoe |
| Address | 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan Japan 460-0001 |
| Telephone | 052-951-1111 |
| naoe.tomoki.wx@mail.hosp.go.jp | |
| Affiliation | National Hospital Organization Nagoya Medical Center Honorary Director |
| scientific contact | |
| Name | Tomoki Naoe |
| Address | 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan Japan |
| Telephone | 052-951-1111 |
| naoe.tomoki.wx@mail.hosp.go.jp | |
| Affiliation | National Hospital Organization Nagoya Medical Center Honorary Director |