ACY-1215 + BCR Pathway Inhibitors for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byJennifer R Brown, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Jennifer R Brown, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

total bilirubin < 2X institutional upper limit of normal (ULN) unless predominantly indirect and therefore likely due to hemolysis or Gilbert's syndrome

creatinine < 2X ULN

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

See 11 more

Exclusion Criteria

Participants who are receiving any other investigational agents

I haven't had chemotherapy or radiotherapy in the last 2 weeks and have recovered from any side effects.

I have been treated with an HDAC inhibitor before.

See 11 more

Treatment Details

Interventions

ACY-1215 (Histone Deacetylase Inhibitor)
Ibrutinib (BCR Pathway Inhibitor)
Idelalisib (BCR Pathway Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.