Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743687
Status:
RECRUITING
Last Update Posted:
2021-02-09
First Post:
2021-02-03
Brief Title:
Zanuburutinib in Relapsed and Refractory iMCD a Prospective Single-center Single-arm Trial
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
The Efficacy and Safety of Zanuburutinib in Relapsed and Refractory Idiopathic Multicentric Castleman Disease iMCD a Prospective Single-center Single-arm Trial
Status:
RECRUITING
Status Verified Date:
2021-02
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:
iMCD
Brief Summary:
To explore the effectiveness and safety of Zanuburutinib in relapsed and refractory idiopathic Multicentric Castlemans disease iMCD patients
Detailed Description:
This is a single center open-labeled single arm prospective study which includes a safety run-in phase The primary endpoint is the overall response rate which includes complete response CR and partial response PR at Week 12 and Week 24 The secondary endpoints include progression-free survival PFS overall survival OS and adverse events There are two phases of the study The first phase is the safety run-in phasewhich plans to enroll 6 patients who would be observed for safety issues for 12 weeks after study drug administration If no Grade 4 CTCAE adverse events AE occurs during this phase the study would enter the second phase if Grade 4 CTCAE AE happens during this phase the study would be terminated In the second phase of the study another 24 patients would be enrolled All enrolled patients would receive the study drug until progression of disease intolerability of the drugs or Week 96 and would be followed every 4 weeks in the first 12 weeks every 12 weeks until Week 48 and every 24 weeks until Week 96 The follow-up phase to assess PFS and OS will last from initiation of study drug to 36 months after enrollment evaluation would be carried out every 24 weeks after Week 96 The total study duration will be 4 years after the last patient starts study medication
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