A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Condition: Acute Myeloid Leukemia (AML); Cancer
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Venetoclax; Azacitidine; Decitabine
Intervention description: Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. On the days that the participant received either azacitidine or decitabine, venetoclax was dosed in clinic and administered prior to these agents.; The azacitidine infusion was prepared and administered per the package insert and given either subcutaneously or intravenously, per institutional practice.; The decitabine infusion was prepared and administered per the package insert and given intravenously, per institutional practice.
Intervention MeSH terms: Azacitidine; Decitabine; Venetoclax
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acute Myeloid Leukemia (AML); Cancer; Treatment-naïve; Venetoclax; Azacitidine; Decitabine; Outpatient setting

Summary:

      A study evaluating the effectiveness and safety of venetoclax, in combination with
      azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML
      who are ineligible for intensive chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has confirmation of acute myeloid leukemia (AML) by World Health
             Organization (WHO) criteria

          -  Participant is deemed by the investigator to be an appropriate candidate for
             outpatient ramp-up of venetoclax

          -  Participant is not eligible to receive treatment with standard cytarabine and
             anthracycline induction regimens

          -  Participant has not received prior treatment for AML (treatment naïve) with the
             exception of hydroxyurea

          -  Participant has no evidence of spontaneous tumor lysis syndrome (TLS) at Screening

          -  Participant can have progressed from myelodysplastic syndrome (MDS) or be considered
             to have secondary AML and could have been treated with growth factors or other agents
             with the exception of hypomethylating agents

          -  Participant has adequate kidney, liver, and hematology laboratory values as detailed
             in the protocol

          -  Has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 3

        Exclusion Criteria:

        Has a history of the following conditions:

          -  Acute promyelocytic leukemia

          -  Known active central nervous system involvement with AML

          -  Positive for HIV (HIV testing is not required)

          -  Positive for hepatitis B or C infection with the exception of those with an
             undetectable viral load within 3 months

          -  Cardiovascular disability status of New York Heart Association Class > 2

          -  Chronic respiratory disease that requires continuous oxygen or any other medical
             condition that in the opinion of the investigator would adversely affect his/her
             participating in this study

          -  Malabsorption syndrome or other condition that precludes enteral route of
             administration

        Has a history of other malignancies within 2 years prior to study entry, with the exception
        of:

          -  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