Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04529772
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2020-08-25
Brief Title:
A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL ACE-LY-312
Sponsor:
Acerta Pharma BV
Organization:
Acerta Pharma BV
Study Overview
Official Title:
Phase 3 Randomized Double-Blind Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab Cyclophosphamide Doxorubicin Vincristine and Prednisone R-CHOP in Subjects 75 Years With Previously Untreated Non-GCB DLBCL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
ESCALADE
Brief Summary:
Phase 3 randomized double-blind placebo-controlled study assessing the efficacy and safety of acalabrutinib plus rituximabcyclophosphamide doxorubicin vincristine and prednisone R-CHOP vs placebo plus R-CHOP in subjects 75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma
Detailed Description:
Phase 3 randomized double-blind placebo-controlled study to evaluate the efficacy and safety of acalabrutinib plus rituximabcyclophosphamide doxorubicin vincristine and prednisone R-CHOP as compared with placebo plus R-CHOP in subjects 75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma activated B-cell ABC and unclassified
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001755-39 | EUDRACT_NUMBER | None | None |