UMIN ID: UMIN000029982
Registered date:15/11/2017
A Retrospective Study of Safety and Efficacy for Re-treatment of Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) classical Hodgkin Lymphoma (cHL)/ systemic Anaplastic Large-cell Lymphoma (sALCL)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | CD30 positive cHL or sALCL |
| Date of first enrollment | 2017/12/15 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Number of Participants who Experience at least one Treatment-Emergent Adverse Events (TEAE), Overall response rate (ORR) |
|---|---|
| Secondary Outcome | Complete response rate (CR rate), Progression-free survival (PFS), Duration of response (DOR), Time to treatment failure (TTF) |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study (such as patients who may be coerced to give consent) |
Related Information
| Primary Sponsor | Takeda Pharmaceutical Company Limited |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Takeda Pharmaceutical Company Limited |
| Secondary ID(s) | JapicCTI-173771 |
Contact
| public contact | |
| Name | Takeda Study Registration Call Center Takeda Study Registration Call Center |
| Address | 12-10, Nihonbashi 2-chome, Chuo-ku,Tokyo 103-8668 Japan 103-8668 |
| Telephone | 03-3278-2111 |
| C25016@sogo-medefi.jp | |
| Affiliation | Takeda Pharmaceutical Company Limited Strategic Medical Research Planning, Global Medical Affairs-Japan, |
| scientific contact | |
| Name | Jumpei Soeda |
| Address | 12-10, Nihonbashi 2-chome, Chuo-ku,Tokyo 103-8668 Japan |
| Telephone | 03-3278-2111 |
| C25016@sogo-medefi.jp | |
| Affiliation | Takeda Pharmaceutical Company Limited Strategic Medical Research Planning, Global Medical Affairs-Japan, |