Pitavastatin + Venetoclax for CLL and AML

Recruiting in Palo Alto (17 mi)

Overseen byElizabeth Brem, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of California, Irvine

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing the safety of combining Pitavastatin and Venetoclax in patients with certain types of leukemia who can't have intensive chemotherapy or whose cancer has come back or not responded to treatment. Pitavastatin may help fight cancer, and Venetoclax kills cancer cells by blocking a protein they need. Venetoclax is used to treat lymphomas and leukemias, but it has significant side effects.

Research Team

Elizabeth Brem, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Eligibility Criteria

Adults diagnosed with chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML), including those new to AML treatment but ineligible for intensive chemotherapy, and patients with relapsed/refractory CLL. Participants must have stable organ function, not be on other statins, agree to use contraception if of childbearing potential, and be able to swallow pills.

Inclusion Criteria

My leukemia is confirmed and I am eligible for VEN therapy.

My CLL has come back or didn't respond to treatment, and I can take VEN alone or with rituximab.

I am newly diagnosed with AML and cannot undergo intensive chemotherapy due to age or health issues.

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Exclusion Criteria

I can swallow pills without difficulty.

I do not have active hepatitis B or C, or I am successfully treated with no drug interactions.

I haven't taken strong CYP3A4 drugs in the last week.

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Treatment Details

Interventions

Pitavastatin (Statins)
Venetoclax (BCL-2 Inhibitor)

Trial OverviewThis phase I trial is testing the safety of combining Pitavastatin with Venetoclax in treating CLL or AML. It's an open-label study where doses are increased gradually to find the highest dose patients can tolerate without severe side effects.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Dose Level 2 (DL2)Experimental Treatment2 Interventions

Patients receive Pitavastatin (PIT) 4 mg PO daily. For CLL patients, they will also receive stabilized Venetoclax (VEN) 400mg PO daily. For AML patients, they will VEN mg PO daily when dosing in combination with azacitidine or decitabine. If DL1 is well tolerated, the next cohort will progress to this dose level.

Group II: Dose Level 1 (DL1)Experimental Treatment2 Interventions

Patients receive Pitavastatin (PIT) 2 mg PO daily. For CLL patients, they will also receive stabilized Venetoclax (VEN) 400mg PO daily. For AML patients, they will VEN mg PO daily when dosing in combination with azacitidine or decitabine. This is the starting dose level for the study.

Group III: Dose Level -1 (DL-1)Experimental Treatment2 Interventions

Patients receive Pitavastatin (PIT) 1 mg PO daily. For CLL patients, they will also receive stabilized Venetoclax (VEN) 400mg PO daily. For AML patients, they will VEN mg PO daily when dosing in combination with azacitidine or decitabine. The 1 mg/day dose level will be held in reserve to allow dose reduction in those patients who cannot tolerate DL1.

Venetoclax is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Venclexta for: