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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.
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
Study Summary
This trialtests the safety of adding a drug to an existing one for people with CLL or AML.
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.Check my eligibility
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.See study design
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 belowSelect...
My leukemia is confirmed and I am eligible for VEN therapy.
Select...
My CLL has come back or didn't respond to treatment, and I can take VEN alone or with rituximab.
Select...
I stopped my statin medication 72 hours before starting VEN-based therapy.
Select...
I have been on a stable dose of VEN for at least 5 days before starting PIT therapy.
Select...
I have recently been diagnosed with CLL and can be treated with VEN and obinatuzumab.
Select...
I agree to use birth control and not donate sperm for 90 days after my last dose.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Number of Participants with Abnormal Laboratory Values and/or Adverse Events that Are Related to Treatment
Partial Response Rates
Percentage of Responders
+2 moreOther outcome measures
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 • NCT013010662%
Headache
2%
Upper abdominal pain
2%
Blood CK increased
2%
Diarrhoea
2%
Fatigue
1%
Atrial septal defect
1%
Diverticulitis
1%
Enterovesical fistula
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
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,995 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,188 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills without difficulty.My leukemia is confirmed and I am eligible for VEN therapy.I do not have active hepatitis B or C, or I am successfully treated with no drug interactions.My CLL has come back or didn't respond to treatment, and I can take VEN alone or with rituximab.I haven't taken strong CYP3A4 drugs in the last week.I do not have acute promyelocytic leukemia.I have AML and was treated with something other than hydroxyurea, or started treatment for MDS after my AML diagnosis.I have HIV with an undetectable viral load and my medication doesn't strongly interact with CYP3A4.I do not have any severe ongoing illnesses that could interfere with the study.I am newly diagnosed with AML and cannot undergo intensive chemotherapy due to age or health issues.I stopped my statin medication 72 hours before starting VEN-based therapy.I have been on a stable dose of VEN for at least 5 days before starting PIT therapy.I have recently been diagnosed with CLL and can be treated with VEN and obinatuzumab.I have not consumed grapefruit or Seville oranges in the last 72 hours.My leukemia has not spread to my brain or spinal cord.I agree to use effective birth control during and for 90 days after the study.I agree to use birth control and not donate sperm for 90 days after my last dose.I have been treated with VEN before.I can take medications by mouth without issues.I do not have any active cancer other than CLL or AML, or I am in remission from another cancer with low risk of recurrence.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My kidneys work well enough for treatment.You have had allergic reactions to medications similar to PEN, PIT, or other statins.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1 (DL1)
- Group 2: Dose Level 2 (DL2)
- Group 3: Dose Level -1 (DL-1)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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