Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
A Global Phase 3 Study of OrelabrutinibBR vsBR in Pts With TN MCL
Sponsor:
InnoCare Pharma Inc
Organization:
InnoCare Pharma Inc
Study Overview
Official Title:
A Randomized Double-Blind Multicenter Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination With Rituximab and Bendamustine BR vs BR in Subjects With Treatment-NaŃ—ve Mantle Cell Lymphoma
Status:
NOT_YET_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:
Compare the efficacy and safety of Orelabrutinib plus bendamustine rituximab versus bendamustine rituximab in previously untreated patients with mantle cell lymphoma MCL
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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