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Histone Deacetylase Inhibitor
ACY-1215 + BCR Pathway Inhibitors for Chronic Lymphocytic Leukemia
Phase 1
Waitlist Available
Led By Jennifer B Brown, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have normal organ and marrow function as defined below: Absolute neutrophil count (ANC) > 1000 K/μL and platelet count > 30,000 K/μL independent of transfusion support. total bilirubin < 2X institutional upper limit of normal (ULN) unless predominantly indirect and therefore likely due to hemolysis or Gilbert's syndrome AST(SGOT)/ALT(SGPT) ≤3X institutional upper limit of normal for ibrutinib arm; within normal limits on the idelalisib arm creatinine < 2X ULN
Age ≥ 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can help people with a certain type of leukemia that has come back or does not respond to other treatments.
Who is the study for?
Adults with Chronic Lymphocytic Leukemia (CLL) that has come back after at least one treatment can join this trial. They need to have certain levels of blood cells, normal organ function, and measurable disease. Participants must use birth control and not be on conflicting medications or have uncontrolled illnesses.Check my eligibility
What is being tested?
The study is testing ACY-1215 combined with either Ibrutinib or Idelalisib in patients whose CLL has relapsed. The goal is to see if these combinations are effective as a new treatment option for CLL.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system, liver problems, digestive issues, fatigue, and an increased risk of infections due to bone marrow suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am not on blood thinners and haven't had major bleeding in the last 6 months.
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I can take care of myself but might not be able to do heavy physical work.
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I have signs of disease like high B cell count, large lymph nodes, spleen issues, or low blood counts with bone marrow involvement.
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My CLL/SLL has returned after treatment and needs more treatment.
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My liver enzymes are within the required range for my treatment arm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determining Maximum Tolerated Dose
Secondary outcome measures
Best Overall Response Rate
Clinical Response Rate
Overall Survival Rate
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Combination of ACY-1215 With IdelalisibExperimental Treatment2 Interventions
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.
Group II: Combination of ACY-1215 With IbrutinibExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACY-1215
2011
Completed Phase 2
~220
Ibrutinib
2014
Completed Phase 3
~1880
Idelalisib
2017
Completed Phase 3
~1660
Find a Location
Who is running the clinical trial?
Acetylon Pharmaceuticals IncorporatedIndustry Sponsor
3 Previous Clinical Trials
60 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,869 Total Patients Enrolled
Jennifer B Brown, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or radiotherapy in the last 2 weeks and have recovered from any side effects.I am 18 years old or older.I have been treated with an HDAC inhibitor before.I have had bad reactions to ibrutinib or idelalisib and agree not to share my study medication.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am not on blood thinners and haven't had major bleeding in the last 6 months.I am not on active chemotherapy for another cancer but may be on hormonal therapy or radiation.I am not taking strong drugs that affect liver enzymes or can stop them for a week.I am not pregnant or breastfeeding if I join this study.I am not on warfarin or vitamin K antagonists, or if I was, I switched and my INR has been normal for 7 days.I can take care of myself but might not be able to do heavy physical work.I have signs of disease like high B cell count, large lymph nodes, spleen issues, or low blood counts with bone marrow involvement.I haven't had major surgery in the last 14 days or minor surgery in the last 7 days.My CLL/SLL has returned after treatment and needs more treatment.My liver enzymes are within the required range for my treatment arm.I am HIV-positive and not on CYP3A4 modulating antiretroviral therapy.I don't have a history of heart rhythm problems or need drugs that affect heart rhythm.I can swallow pills.My organ and bone marrow functions are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Combination of ACY-1215 With Ibrutinib
- Group 2: Combination of ACY-1215 With Idelalisib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any participants being accepted at this point for the trial?
"As per information presented on clinicaltrials.gov, this trial is no longer recruiting individuals. Initially posted in May 2016 and last updated June 2022, the study has concluded its candidate intake; however, 1684 other trials are still actively seeking participants at present."
Answered by AI
Have any other research initiatives focused on the utilization of ACY-1215?
"Presently, a total of 167 live clinical trials into ACY-1215 are administer with 25 in the third phase. Most testing is taking place in Las Vegas, Nevada; however 7734 sites across the United States offer this medication for trial participation."
Answered by AI
To what extent is this research study accommodating participants?
"Unfortunately, recruitment for this study has ended. It was first posted on May 1st 2016 and last updated on June 13th 2022. If you're looking to apply elsewhere, there are presently 1517 studies searching for participants with leukemia and 167 trials enlisting those interested in receiving ACY-1215 treatment."
Answered by AI
What medical conditions has ACY-1215 been utilized to treat?
"ACY-1215 has been clinically tested to treat relapsed chronic lymphocytic leukemia, mantle cell lymphoma (mcl), and multiple B-cell lymphomas."
Answered by AI
Has ACY-1215 been given the green light by the FDA?
"ACY-1215's safety was scored a 1 due to its Phase One status, which implies limited evidence of efficacy and security."
Answered by AI
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