Ignite Creation Date:
2024-05-06 @ 7:27 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02538614
Status:
TERMINATED
Last Update Posted:
2020-11-25
First Post:
2015-08-31
Brief Title:
Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 1b2 Study of Idelalisib in Combination With BI 836826 in Subjects With Chronic Lymphocytic Leukemia
Status:
TERMINATED
Status Verified Date:
2020-11
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:
This study consists of 2 parts Phase 1b and Phase 2 Phase 1b will evaluate the safety and tolerability of the combination of idelallisib with the anti-CD37 monoclonal antibody BI 836826 in participants with relapsedrefractory chronic lymphocytic leukemia RR CLL and establish the high recommended Phase 2 combination dose highRP2D as well as an alternate lower recommended Phase 2 combination dose lowRP2D Phase 2 will determine the rates of complete response CR and of minimal residual disease MRD negativity with the combination at the highRP2D and the lowRP2D in participants with RR CLL
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