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BCL-2 Inhibitor

Pitavastatin + Venetoclax for CLL and AML

Phase 1
Waitlist Available
Led By Elizabeth Brem, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed AML or CLL, otherwise eligible for VEN-containing therapy at Screening
Relapsed/refractory CLL eligible to receive single-agent VEN or VEN in combination with rituximab at Screening.
Must not have
Patients who are unable to swallow pills are excluded.
Patients with acute promyelocytic leukemia are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up samples will be collected at the following timepoints: pre-ven dose during screening, cycle 1 day 1 pre-ven and pit dose, cycle 1 day 1 post dose sampling at 1, 2, 4, 8, 24 hours after first pit dose. each cycle is 28 days.
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
This 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.
What are the potential side effects?
Potential side effects may include liver issues due to elevated enzymes, digestive problems from oral administration difficulties, muscle pain as a common statin issue, blood cell count changes affecting immunity and clotting risk increase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia is confirmed and I am eligible for VEN therapy.
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My CLL has come back or didn't respond to treatment, and I can take VEN alone or with rituximab.
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I stopped my statin medication 72 hours before starting VEN-based therapy.
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I have been on a stable dose of VEN for at least 5 days before starting PIT therapy.
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I have recently been diagnosed with CLL and can be treated with VEN and obinatuzumab.
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I agree to use birth control and not donate sperm for 90 days after my last dose.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can swallow pills without difficulty.
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I do not have acute promyelocytic leukemia.
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I do not have any severe ongoing illnesses that could interfere with the study.
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My leukemia has not spread to my brain or spinal cord.
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I have been treated with VEN before.
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I can take medications by mouth without issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~samples will be collected at the following timepoints: pre-ven dose during screening, cycle 1 day 1 pre-ven and pit dose, cycle 1 day 1 post dose sampling at 1, 2, 4, 8, 24 hours after first pit dose. each cycle is 28 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and samples will be collected at the following timepoints: pre-ven dose during screening, cycle 1 day 1 pre-ven and pit dose, cycle 1 day 1 post dose sampling at 1, 2, 4, 8, 24 hours after first pit dose. each cycle is 28 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Response Rate
Identifying Dose Limiting Toxicities (DLTs) for PIT administered with VEN-containing SOC regimens
Identifying overall Adverse Event Profile of PIT when given with VEN-containing SOC regimens
+2 more
Secondary study objectives
Number of Participants with Abnormal Laboratory Values and/or Adverse Events that Are Related to Treatment
Partial Response Rates
Percentage of Responders
+2 more
Other study objectives
Composite of PK parameters of VEN and PIT summarized by PIT dose level
Composite of dynamic BH3 profiling in priming of ex vivo AML and CLL specimens

Side effects data

From 2013 Phase 4 trial • 252 Patients • NCT01301066
2%
Headache
2%
Upper abdominal pain
2%
Blood CK increased
2%
Diarrhoea
2%
Fatigue
1%
Enterovesical fistula
1%
Diverticulitis
1%
Atrial septal defect
1%
Transient ischaemic attack
1%
Multiple fractures
1%
Respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Chest pain
1%
Gastroenteritis
1%
Gastroenteritis viral
1%
Herpes dermatitis
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pitavastatin 4 mg QD
Pravastatin 40 mg QD

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pitavastatin
FDA approved
Venetoclax
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pitavastatin, an HMG-CoA Reductase Inhibitor, primarily lowers cholesterol but may also inhibit cancer cell proliferation and induce apoptosis. Venetoclax, a BCL-2 Inhibitor, targets the BCL-2 protein that helps cancer cells survive, promoting their apoptosis. These mechanisms are important for CLL patients as they offer targeted approaches to kill cancer cells, potentially improving disease management and outcomes.

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
559 Previous Clinical Trials
1,930,117 Total Patients Enrolled
United States Department of DefenseFED
898 Previous Clinical Trials
332,717 Total Patients Enrolled
Elizabeth Brem, MDPrincipal Investigator - Chao Family Comprehensive Cancer Center
Regents of the University of California, University of California-Irvine Medical Center

Media Library

Venetoclax (BCL-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04512105 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: Dose Level 1 (DL1), Dose Level 2 (DL2), Dose Level -1 (DL-1)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT04512105 — Phase 1
Venetoclax (BCL-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04512105 — Phase 1
~1 spots leftby Oct 2025