Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04370405
Status:
UNKNOWN
Last Update Posted:
2020-05-11
First Post:
2020-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of YY-20394 in Participants With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma
Sponsor:
Shanghai YingLi Pharmaceutical Co. Ltd.
Organization:
Study Overview
Official Title:
A Phase 2, Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of YY-20394 in Subjects With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
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:
This is a study designed to evaluate the efficacy and safety of oral YY-20394 in patients with R/R follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies.
Detailed Description:
The study will be conducted in China to provide safety and efficacy data from this region. A Safety Run-in will be conducted to confirm the safety of the recommended Phase 2 dose (RP2D), 80 mg once daily, in a Asian population. PK samplings at Cycle 1, Day 1 will be taken.
Study Oversight
Has Oversight DMC:
True
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?: