JRCT ID: jRCT2031220191
Registered date:07/07/2022
Post-marketing Surveillance Protocol Number; CABL001A1401
Basic Information
| Recruitment status | Not Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Chronic myeloid leukemia resistant or intolerant to pretreatment drugs |
| Date of first enrollment | 01/07/2022 |
| Target sample size | 440 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | To assess the safety profile of the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity) |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | All patients treated with asciminib |
| Exclude criteria | none |
Related Information
| Primary Sponsor | Toshiya Sugimoto |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Novartis Direct |
| Address | Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan Tokyo Japan 105-6333 |
| Telephone | +81-120003293 |
| sm.pms@novartis.com | |
| Affiliation | Novartis Pharma. K.K. |
| Scientific contact | |
| Name | Sugimoto Toshiya |
| Address | Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan Tokyo Japan 105-6333 |
| Telephone | +81-120003293 |
| sm.pms@novartis.com | |
| Affiliation | Novartis Pharma. K.K. |