Venetoclax + Cytarabine for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+108 other locations

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 under 75 and my bilirubin levels are within the normal range.

My condition is not due to leukemia affecting my organs.

+29 more

Exclusion Criteria

I have AML and may have been treated with hydroxyurea or for myelodysplastic syndrome, but not with cytarabine.

I have been diagnosed with acute promyelocytic leukemia.

I am HIV positive and aware of potential medication interactions.

+16 more

Participant Groups

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: