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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

Must not have

Prior therapy with an HDAC inhibitor

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with an HDAC inhibitor before.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am not pregnant or breastfeeding if I join this study.

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I am HIV-positive and not on CYP3A4 modulating antiretroviral therapy.

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I am not on warfarin or vitamin K antagonists, or if I was, I switched and my INR has been normal for 7 days.

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I haven't had major surgery in the last 14 days or minor surgery in the last 7 days.

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I can swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determining Maximum Tolerated Dose

Secondary study objectives

Best Overall Response Rate

Clinical Response Rate

Overall Survival Rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~200

Ibrutinib

2014

Completed Phase 4

~2060