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

Part of paid clinical trials in Tampa, Florida.

Sponsor
AbbVie
Study ID
NCT03069352
Phase
PHASE3
Status
Completed

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    tablet
  • Venetoclax — DRUG
    tablet
  • Cytarabine — DRUG
    Subcutaneous injection

Study Details

The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).

Key Dates

Start date
May 23, 2017
Status verified
Aug 2025
Primary completion
Feb 15, 2019
Completion
Aug 21, 2025

Study Design

Enrollment
211 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax + Low Dose Cytarabine (LDAC)
    Venetoclax 600 mg orally every day (QD) plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
  • Placebo Comparator: Placebo + LDAC
    Matching placebo to venetoclax orally QD plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

Primary Outcome Measure

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. ]

Locations (6)

FacilityCityStateZIPSite coordinators
H. Lee Moffit Cancer Center /ID# 164273TampaFlorida33612-
Norton Cancer Institute /ID# 158998LouisvilleKentucky40202-3700-
Univ of Pittsburgh Med Ctr /ID# 158997PittsburghPennsylvania15232-
Univ TX, MD Anderson /ID# 159678HoustonTexas77030-
Swedish Medical Center /ID# 161280SeattleWashington98104-
Gundersen Health System /ID# 164272La CrosseWisconsin54601-

Find similar trials in Tampa, FL

By research site
H. Lee Moffit Cancer Center· Tampa, FLNorton Cancer Institute· Louisville, KYUniv of Pittsburgh Med Ctr· Pittsburgh, PAUniv TX, MD Anderson· Houston, TXSwedish Medical Center· Seattle, WAGundersen Health System· La Crosse, WI

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