A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT02993523
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Solution for subcutaneous or intravenous administration.
  • Venetoclax — DRUG
    Tablet
  • Placebo — DRUG
    Matching placebo tablet

Study Details

Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed. Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own. This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are \>= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants. In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine. Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.

Key Dates

Start date
Feb 2, 2017
Status verified
May 2026
Primary completion
Dec 1, 2021
Completion
Jun 15, 2026

Study Design

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

Arms

  • Placebo Comparator: Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2
    Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, every day (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, subcutaneously (SC) or intravenously (IV), QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
  • Active Comparator: Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
    Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
  • Active Comparator: Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
    Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021) ]

Locations (24)

FacilityCityStateZIPSite coordinators
City of Hope /ID# 154105DuarteCalifornia91010-
University of California, Los Angeles /ID# 154107Los AngelesCalifornia90095-
University of California, Davis Comprehensive Cancer Center /ID# 162725SacramentoCalifornia95817-
Emory Midtown Infectious Disease Clinic /ID# 162534AtlantaGeorgia30322-
Northwestern University Feinberg School of Medicine /ID# 201133ChicagoIllinois60611-2927-
University of Chicago Medicine /ID# 154108ChicagoIllinois60637-1426-
Fort Wayne Medical Oncology /ID# 157190Fort WayneIndiana46804-
Cotton-O'Neil Clinical Res Ctr /ID# 155136TopekaKansas66606-
Norton Cancer Institute /ID# 154992LouisvilleKentucky40202-3700-
EMMC Cancer Care /ID# 154991BrewerMaine04412-
Johns Hopkins University /ID# 154104BaltimoreMaryland21287-
Beth Israel Deaconess Medical Center /ID# 201155BostonMassachusetts02215-5400-
Dana-Farber Cancer Institute /ID# 167009BostonMassachusetts02215-
Massachusetts General Hospital /ID# 200752BostonMassachusetts02114-
Sepctrum Health Medical Center /ID# 159522Grand RapidsMichigan49503-
Columbia Univ Medical Center /ID# 154101New YorkNew York10032-3725-
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077New YorkNew York10065-6007-
Duke Cancer Center /ID# 154106DurhamNorth Carolina27710-3000-
University of Pittsburgh MC /ID# 154102PittsburghPennsylvania15260-
Tennessee Oncology-Nashville Centennial /ID# 200854NashvilleTennessee37203-1632-
University of Texas MD Anderson Cancer Center /ID# 154100HoustonTexas77030-
Baylor Scott & White Medical Center- Temple /ID# 157191TempleTexas76508-0001-
University of Utah /ID# 157192Salt Lake CityUtah84112-5500-
University Of Vermont Medical /ID# 157196BurlingtonVermont05405-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUniversity of California, Los Angeles· Los Angeles, CAUniversity of California, Davis Comprehensive Cancer Center· Sacramento, CAEmory Midtown Infectious Disease Clinic· Atlanta, GANorthwestern University Feinberg School of Medicine· Chicago, ILUniversity of Chicago Medicine· Chicago, IL

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