Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285370
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-08-16
Brief Title:
A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy
Sponsor:
Kyowa Kirin China Pharmaceutical Co Ltd
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
An Open-Label Multicenter Single Arm Study to Evaluate the Efficacy and Safety of Anti-CCR4 Monoclonal Antibody Mogamulizumab KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of mogamulizumab KW-0761 in chinese subjects with mycosis fungoides or sézary syndrome previously treated with systemic therapy
Detailed Description:
This is an open-label multicenter single arm study This study consists of three parts the Pretreatment Period the Treatment Period and the Follow-up Period Subjects who meet all of eligibility criteria by the screening examination will be enrolled into the study and start treatment with mogamulizumab within 30 days after obtaining consent Mogamulizumab will be administered at the dose of 10 mgkg as an intravenous iv infusion over at least 1 hour on Days 1 8 15 and 22 of Cycle 1 and on Days 1 and 15 of subsequent cycles Each treatment cycle is set as 28 days Subjects will continue the treatment of mogamulizumab until any of the criteria for study withdrawal is met After stopping treatment the end-of treatment examination will be conducted within 30 days after the last doseThe primary efficacy analysis will be conducted once all subjects terminate treatment by the confirmation of PDdrug intoleranceunacceptable toxicity or 12 months after the date of the first mogamulizumab administration of the last subject of entire study whichever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20230672 | OTHER | National Medical Products Administration | None |