JRCT ID: jRCT2011210002
Registered date:16/04/2021
44-301 : Special Drug Use-Results Survey of VELEXBRU (PCNSL)
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | relapsed or refractory primary central nervous system lymphoma (PCNSL) |
Date of first enrollment | 28/05/2020 |
Target sample size | 100 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | Occurrence status of adverse drug reactions and infections, Occurrence status of adverse drug reactions corresponding to specified safety concerns, Factors that are considered to affect safety Specified safety concerns: Infections,Severe skin disorders, Myelosuppression, Hypersensitivity, Interstitial lung diseases, Hepatic function disorders, Hemorrhage |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | All patients with PCSNL for whom VELEXBLU is administered |
Exclude criteria | patients who have not received VELEXBLU |
Related Information
Primary Sponsor | Kuro Toshihiko |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Toshihiko Kuro |
Address | 1 -5 Doshomachi 2-chome, Chuo-ku, Osaka-shi, Osaka 541-8526, Japan Osaka Japan 541-8526 |
Telephone | +81-6-6222-5501 |
kuro@ono-pharma.com | |
Affiliation | Ono Pharmaceutical Co.,LTD |
Scientific contact | |
Name | Toshihiko Kuro |
Address | 1 -5 Doshomachi 2-chome, Chuo-ku, Osaka-shi, Osaka 541-8526, Japan Osaka Japan 541-8526 |
Telephone | +81-6-6222-5501 |
kuro@ono-pharma.com | |
Affiliation | Ono Pharmaceutical Co.,LTD |