Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2. - Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 60 days. - Blast percentage in bone marrow before transplant must be < 10%. - Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant. - Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol. - Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.

Exclusion Criteria

  • History of disease progression during prior treatment with venetoclax. - History of any other malignancy within 2 years prior to study entry, except for: Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; Myelodysplastic Syndrome, Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation). - Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. - Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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)
  • Drug: Venetoclax
    Tablet; Oral
    Other names:
    • ABT-199
    • GDC-0199
    • VENCLEXTA
  • Drug: Azacitidine
    Subcutaneous (SC) or intravenous (IV) injection
  • Other: Best Supportive Care (BSC)
    BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
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).
  • Drug: Venetoclax
    Tablet; Oral
    Other names:
    • ABT-199
    • GDC-0199
    • VENCLEXTA
  • Drug: Azacitidine
    Subcutaneous (SC) or intravenous (IV) injection
  • Other: Best Supportive Care (BSC)
    BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
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)
  • Other: Best Supportive Care (BSC)
    BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.

Recruiting Locations

More Details

NCT ID
NCT04161885
Status
Active, not recruiting
Sponsor
AbbVie

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.