Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-06 @ 2:08 AM
Study NCT ID:
NCT02787369
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2016-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase Ib Study of ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed Chronic Lymphocytic Leukemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
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 research study is studying a drug called ACY-1215 in combination with ibrutinib or idelalisib as a possible treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL).
Detailed Description:
This research study is a Phase I clinical trial. The investigators are studying the combination of the B-cell receptor (BCR) pathway inhibitors with ricolinostat, in order to try to enhance both the initial remission and to help improve the response in those who relapse after a first inhibitor and are receiving a second.
The FDA (the U.S. Food and Drug Administration) has not approved ACY-1215 as a treatment for any disease. ACY-1215 or ricolinostat is a histone deacetylase inhibitor, specifically HDAC6. The FDA has approved idelalisib as well as ibrutinib as treatment options for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL).
The FDA (the U.S. Food and Drug Administration) has not approved ACY-1215 as a treatment for any disease. ACY-1215 or ricolinostat is a histone deacetylase inhibitor, specifically HDAC6. The FDA has approved idelalisib as well as ibrutinib as treatment options for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: