A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Source: ClinicalTrials.gov results for NCT03069352 (opens in a new tab)· Licence: public-domain

First posted 28 Feb 2020 · Last update posted 16 Oct 2026 · Imported 26 Oct 2026 from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

1. Overall Survival (OS)

   Time frame

   From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.

   Measure

   Median

   Unit

   months

   • Venetoclax + Low Dose Cytarabine (LDAC) vs Placebo + Low Dose Cytarabine (LDAC)Superiority

     Estimate

     0.749Hazard Ratio (HR)

     95% CI, two-sided

     0.524 to 1.071

     p-value

     0.114

     Method

     Log Rank

   • Venetoclax + Low Dose Cytarabine (LDAC) vs Placebo + Low Dose Cytarabine (LDAC)Superiority

     Estimate

     0.743Hazard Ratio (HR)

     95% CI, two-sided

     0.521 to 1.061

     p-value

     0.103

     Method

     Log Rank

Serious adverse events

Time frame: All protocol-related serious adverse events and nonserious adverse events were collected from informed consent until study drug start, up to 21 days. All adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 90.0 months for VEN + LDAC and 33.3 months for PBO + LDAC. Median time on follow-up: VEN + LDAC (8.4 months); PBO + LDAC (4.1 months)

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.