Clinical Trials

Inclusion Criteria:

• Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
• Subject must be diagnosed with AML by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic SCT or have received allogeneic SCT within the past 60 days. All types and WHO categories of AML56 and any number of previous lines of therapy may be included.
• 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.
• 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.