ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL
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|ClinicalTrials.gov Identifier: NCT02787369|
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Chronic Lymphoid Leukemia||Drug: ACY-1215 Drug: Ibrutinib Drug: Idelalisib||Phase 1|
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 Lymphocyic Leukemia (CLL).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study of ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed Chronic Lymphocytic Leukemia|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2022|
Experimental: Combination of ACY-1215 With Ibrutinib
ACY-1215 and Ibrutinib will be administered orally continuously, with 28 consecutive days arbitrarily defined as a treatment cycle. The dose level will be predetermine.
Other Name: Ricolinostat
Other Name: Imbruvica
Experimental: Combination of ACY-1215 With Idelalisib
ACY-1215 and Idelalisib will be administered orally continuously, with 28 consecutive days arbitrarily defined as a treatment cycle. The dose level will be predetermine.
Other Name: Ricolinostat
Other Name: Zydelig
- Determining Maximum Tolerated Dose [ Time Frame: 2 years ]Determining Maximum Tolerated Dose
- Clinical Response Rate [ Time Frame: 2 years ]Clinical Response Rate
- Best Overall Response Rate [ Time Frame: 2 years ]Best Overall Response Rate
- Progression Free Survival Rate [ Time Frame: 2 years ]Progression Free Survival Rate
- Overall Survival Rate [ Time Frame: 2 years ]Overall Survival Rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787369
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jennifer B Brown, MD, PhD||Dana-Farber Cancer Institute|