Pitavastatin in Combination With Venetoclax for Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT04512105
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pitavastatin — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO

Study Details

This is a phase I, dose-escalation, open-label clinical trial determining the safety and tolerability of adding Pitavastatin to Venetoclax in subjects with chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML). These are subjects who are newly diagnosed subjects with AML who are ineligible for intensive induction chemotherapy, relapsed/refractory CLL or newly diagnosed CLL.

Key Dates

Start date
Dec 2, 2020
Status verified
Sep 2025
Primary completion
Jul 20, 2024
Completion
Feb 5, 2025

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -1 (DL-1)
    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.
  • Experimental: Dose Level 1 (DL1)
    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.
  • Experimental: Dose Level 2 (DL2)
    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.

Primary Outcome Measure

Maximum Tolerated Dose for PIT administered with VEN-containing Standard of Care (SOC) regimens [ Time Frame: From the start date of treatment until 30 days after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 2 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868-

Find similar trials in Orange, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

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