A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
AbbVie
Study ID
NCT04161885
Phase
PHASE3
Status
Terminated

Conditions

  • Acute Myeloid Leukemia (AML)
  • Cancer

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Tablet; Oral
  • Azacitidine — DRUG
    Subcutaneous (SC) or intravenous (IV) injection
  • Best Supportive Care (BSC) — OTHER
    BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.

Study Details

The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

Key Dates

Start date
Feb 26, 2020
Status verified
Jun 2026
Primary completion
Sep 23, 2025
Completion
Sep 23, 2025

Study Design

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

Arms

  • Experimental: Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care
    Participants will be administered various doses and dose regiments of venetoclax and AZA. Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days)
  • Experimental: Part 2: Arm B - Best Supportive Care (BSC)
    Participants will receive treatment as prescribed by their physician according to the BSC for up to 24 cycles (1 cycle = 28 days)
  • Experimental: Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC
    Participants will be administered with venetoclax and AZA at a dose level determined in Part 1 in addition to best supportive care (when required). Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days).

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1) [ Time Frame: Up to 28 days ]

Locations (43)

FacilityCityStateZIPSite coordinators
Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711ScottsdaleArizona85258-4547-
University of Arizona Cancer Center - Tucson /ID# 242507TucsonArizona85724-
University of Arkansas for Medical Sciences /ID# 239804Little RockArkansas72205-
City of Hope /ID# 213681DuarteCalifornia91010-
UCHSC Anschultz Cancer Pavilion /ID# 215618AuroraColorado80045-2517-
Colorado Blood Cancer Institute /ID# 215980DenverColorado80218-
Mayo Clinic Hospital Jacksonville /ID# 239710JacksonvilleFlorida32224-
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985OrlandoFlorida32804-5505-
Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 215840ChicagoIllinois60611-
The University of Chicago Medical Center /ID# 215616ChicagoIllinois60637-1443-
Loyola University Medical Ctr /ID# 215617MaywoodIllinois60153-
Indiana Blood & Marrow Transpl /ID# 215842IndianapolisIndiana46237-
Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 213834New OrleansLouisiana70121-
University of Maryland, Baltimore /ID# 213855BaltimoreMaryland21201-
Massachusetts General Hospital /ID# 215765BostonMassachusetts02114-
Karmanos Cancer Institute - Dresner Clinic /ID# 214581DetroitMichigan48201-2013-
Masonic Cancer Center /ID# 239492MinneapolisMinnesota55455-
Mayo Clinic - Rochester /ID# 214685RochesterMinnesota55905-0001-
University of Mississippi Medical Center /ID# 239343JacksonMississippi39216-4500-
The John Theurer Cancer /ID# 215251HackensackNew Jersey07601-
Roswell Park Cancer Institute /ID# 217857BuffaloNew York14263-
Columbia University Medical Center /ID# 240875New YorkNew York10032-3729-
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680New YorkNew York10065-6007-
Weill Cornell Medical College /ID# 214887New YorkNew York10065-
Montefiore Medical Center - Moses Campus /ID# 241669The BronxNew York10467-
University of North Carolina /ID# 215814Chapel HillNorth Carolina27514-
Atrium Health Wake Forest Baptist Medical Center /ID# 239210Winston-SalemNorth Carolina27157-
UC Health - Cincinnati /ID# 239263CincinnatiOhio45267-2800-
University Hospitals Cleveland Medical Center /ID# 239260ClevelandOhio44106-
University of Oklahoma, Stephenson Cancer Center /ID# 215611Oklahoma CityOklahoma73104-5418-
Oregon Health and Science University /ID# 215874PortlandOregon97239-
Penn State Hershey Medical Ctr /ID# 217120HersheyPennsylvania17033-2360-
Children's Hospital of Philadelphia - Main /ID# 215410PhiladelphiaPennsylvania19104-4319-
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 214518PhiladelphiaPennsylvania19104-
Duplicate_Allegheny General Hospital /ID# 216756PittsburghPennsylvania15212-
UPMC Hillman Cancer Ctr /ID# 213715PittsburghPennsylvania15232-
TriStar Centennial Medical Center /ID# 218750NashvilleTennessee37203-1551-
Texas Oncology - Medical City Dallas /ID# 216720DallasTexas75230-
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735DallasTexas75246-2003-
Texas Transplant Institute /ID# 214691San AntonioTexas78229-
Virginia Commonwealth University Medical Center Main Hospital /ID# 239203RichmondVirginia23219-
Fred Hutchinson Cancer Research Center /ID# 214436SeattleWashington98109-1024-
Univ of Wisconsin Hosp/Clinics /ID# 216096MadisonWisconsin53792-0001-

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Arizona Oncology - Scottsdale - Cancer Transplant Institute· Scottsdale, AZUniversity of Arizona Cancer Center - Tucson· Tucson, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARCity of Hope· Duarte, CAUCHSC Anschultz Cancer Pavilion· Aurora, COColorado Blood Cancer Institute· Denver, CO

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