Venetoclax + Cytarabine for Acute Myeloid Leukemia

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests if venetoclax with low-dose cytarabine helps untreated AML patients who can't have intensive chemotherapy. Venetoclax works by blocking a protein that keeps cancer cells alive, making it easier to kill them. Venetoclax has been effective in treating leukemia when used with other treatments.

Eligibility Criteria

This trial is for treatment-naive patients with acute myeloid leukemia who are unfit for intensive chemotherapy. They must be aged ≥75 or 18-74 with certain health conditions, have an ECOG performance status of 0-3, adequate liver and kidney function, a life expectancy of at least 12 weeks, and agree to contraception if applicable. Exclusions include prior malignancies (with some exceptions), known CNS involvement by AML, active hepatitis B/C infections, HIV infection.

Inclusion Criteria

My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

I am over 55 and have not had a period for at least 12 months without another health reason.

I am 55 or younger, haven't had a period for a year without other causes, and my FSH level is over 40.

My liver is not working perfectly, and my bilirubin levels are a bit high.

I have AML and can't undergo intensive chemotherapy.

I have a heart condition that needed treatment or my heart's pumping ability is reduced.

My kidney function is low but not severely impaired.

I have some trouble doing my daily activities but don't need constant care.

I have had surgery to remove my ovaries or uterus, making me unable to have children.

I am 75 years old or older.

Exclusion Criteria

I have been diagnosed with acute promyelocytic leukemia.

I have not taken strong/moderate CYP3A inhibitors in the last 7 days.

My heart condition limits my daily activities beyond basic rest.

My cervical or breast cancer was treated early and effectively.

I have been treated with venetoclax or am currently in a study with investigational drugs.

I have been diagnosed with a type of skin cancer that is either basal cell or squamous cell.

I cannot take medicine by mouth due to a digestive condition.

I do not have any uncontrolled infections needing treatment.

I had a blood disorder like myelofibrosis or leukemia before my current AML diagnosis.

My leukemia has spread to my brain or spinal cord.

Treatment Details

The study aims to determine if venetoclax combined with low-dose cytarabine improves survival compared to low-dose cytarabine and placebo in elderly or less fit patients with AML. Participants will either receive the combination therapy or the standard care (cytarabine plus placebo) to assess effectiveness.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Venetoclax + Low Dose Cytarabine (LDAC)Experimental Treatment2 Interventions

Venetoclax 600 mg orally every day (QD) plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

Group II: Placebo + LDACPlacebo Group2 Interventions

Matching placebo to venetoclax orally QD plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

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

🇺🇸 Approved in United States as Cytosar-U for: