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Recurrent Chronic Lymphoid LeukemiaPhase 1NCT02787369

ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL

A Phase 1 study testing ACY-1215, Ibrutinib and Idelalisib in people with Recurrent Chronic Lymphoid Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Chronic Lymphoid Leukemia
What is being tested?
ACY-1215, Ibrutinib and Idelalisib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
May 2016to Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have confirmed CLL/SLL relapsed after at least one prior therapy and currently in need of treatment by IWCLL 2008 criteria
  • Age ≥ 18
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  • For the ibrutinib arm only: participants must not currently require ongoing anticoagulation for any reason, or have had any major bleeding events within 6 months of enrollment
  • 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.
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  • 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
  • Participants must have measurable disease, including at least one of the following: an absolute B cell count > 5000/uL, OR lymphadenopathy with at least one lymph node > 2 cm in long axis, OR palpable splenomegaly, OR cytopenias (Hb < 11 g/dL or platelets < 100K) together with bone marrow infiltration
  • The effects of the drugs studied in this research protocol on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of treatment administration.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Participants who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
  • Participants who are receiving any other investigational agents.
  • Prior therapy with an HDAC inhibitor.
  • Participants with a history of poor tolerance to either ibrutinib or idelalisib should not be enrolled on the arm containing that drug, but may be enrolled to the other arm. Must agree not to share study medication with another person.
  • Participants requiring any medications or substances that are strong inducers or inhibitors of CYP3A4 are ineligible. Those who may discontinue these medications are eligible after a 7 day washout period. . Mild or moderate inducers or inhibitors of CYP3A4 are permitted but moderate inhibitors will require dose reduction of ibrutinib (see section 5.5).
  • 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.
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  • Pregnant women are excluded from this study because ACY-1215, as well as both ibrutinib and idelalisib, have unknown effects on a developing fetus or newborn. Breastfeeding should be discontinued if the mother is treated on this research protocol.
  • HIV-positive participants on CYP3A4 modulating antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ACY-1215, ibrutinib or idelalisib. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
  • Participants who require active chemotherapy for another cancer. Those requiring hormonal therapy or radiation therapy may be considered for enrollment on a case by case basis.
  • Corrected QT interval using Fridericia's formula (QTcF) value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at screening; previous history of drug-induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on ECG.
  • Positive hepatitis B virus (HBV) surface antigen, or core antibody; and known or suspected active hepatitis C virus (HCV) infection, for the idelalisib arm. On the ibrutinib arm, patients with positive hepatitis B surface antigen may be appropriately treated and enrolled on this study as long as their HBV DNA / viral load is undetectable. Patients positive for hepB core antibody and negative for surface antigen are eligible for the ibrutinib arm, as are patients with hepatitis C.
  • Subjects requiring anticoagulation with warfarin or vitamin K antagonists are excluded from the ibrutinib arm. If previously on these drugs and switched, INR must be normal for 7 days prior to enrollment.
  • Subjects enrolling on the ibrutinib arm must not have had major surgery within 14 days, or minor surgery within 7 days.
  • Participant must be able to swallow pills.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Phase Ib Study of ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed Chronic Lymphocytic Leukemia

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).

Read the 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).

Being tested
ACY-1215, Ibrutinib, Idelalisib
Keywords
Refractory Leukemia, Leukemia
Medical subject headings
Leukemia, B-Cell, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACY-1215Drug

    Also called Ricolinostat

  • IbrutinibDrug

    Also called Imbruvica

  • IdelalisibDrug

    Also called Zydelig

Study groups in NCT02787369
Study groupRoleWhat they receive
Combination of ACY-1215 With IbrutinibExperimentalACY-1215 and Ibrutinib will be administered orally continuously, with 28 consecutive days arbitrarily defined as a treatment cycle. The dose level will be predetermine.
Receives: Drug: ACY-1215; Drug: Ibrutinib
Combination of ACY-1215 With IdelalisibExperimentalACY-1215 and Idelalisib will be administered orally continuously, with 28 consecutive days arbitrarily defined as a treatment cycle. The dose level will be predetermine.
Receives: Drug: ACY-1215; Drug: Idelalisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determining Maximum Tolerated Dose

    Determining Maximum Tolerated Dose

    Measured: 2 years

Secondary outcomes (4)

  1. Clinical Response Rate

    Clinical Response Rate

    Measured: 2 years

  2. Best Overall Response Rate

    Best Overall Response Rate

    Measured: 2 years

  3. Progression Free Survival Rate

    Progression Free Survival Rate

    Measured: 2 years

  4. Overall Survival Rate

    Overall Survival Rate

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionApr 2026
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02787369
Sponsor's protocol ID
15-558
Status last verified
May 2026
First submitted
6 May 2016
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACY-1215, Ibrutinib and Idelalisib in people with Recurrent Chronic Lymphoid Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determining Maximum Tolerated Dose (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02787369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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