A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML)
Condition: Acute Myelogenous Leukemia; AML; Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: ABT-199
Intervention description: Tablet
Intervention MeSH terms: Venetoclax
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: GDC-0199; Acute Myelogenous Leukemia; AML; ABT-199; Acute Myeloid Leukemia; Myeloid Leukemia

Summary:

      This was a Phase 2, open-label, multicenter study evaluating the preliminary efficacy and
      safety of venetoclax (ABT-199) administered orally in participants with acute myelogenous
      leukemia (AML).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological or cytological confirmation of relapsed or refractory acute myelogenous
             leukemia (AML) (by World Health Organization [WHO] classification) or untreated AML in
             participants who are unfit for intensive therapy.

          2. Participant has an Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to
             2.

          3. Participant must have adequate renal function as demonstrated by a calculated
             creatinine clearance ≥ 50 mL/min; determined via urine collection for 24-hour
             creatinine clearance or by the Cockcroft Gault formula using ideal body mass (IBM)
             instead of mass.

          4. Participant must have adequate liver function as demonstrated by:

               -  aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN)*

               -  alanine aminotransferase (ALT) ≤ 3.0 × ULN*

               -  bilirubin ≤ 1.5 × ULN* *unless considered due to leukemic organ involvement.
                  (Participants with Gilbert's Syndrome may have had a bilirubin > 1.5 × ULN per
                  discussion between the investigator and AbbVie medical monitor)

        Exclusion Criteria:

          1. Participant has received acute anti-cancer therapy including chemotherapy,
             immunotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or
             5 half-lives (whichever is shorter) prior to first dose of ABT-199.

          2. Participant has received a monoclonal antibody for anti-neoplastic intent within 8
             weeks prior to the first dose of study drug.

          3. Participant has received potent Cytochrome P450, family 3, subfamily A (CYP3A)
             inducers (such as rifampin, carbamazepine, phenytoin and St. John's wort) and warfarin
             or requires the use of warfarin (due to potential drug-drug interactions that may
             potentially increase the exposure of warfarin and complications of this effect) within
             7 days prior to the first dose of study drug.

          4. Participant has received CYP3A inhibitors (such as fluconazole, ketoconazole, and
             clarithromycin) within 5 days prior to the first dose of study drug.

          5. Participant has a white blood cell count > 25 x 10^9/L.

          6. Participant has acute promyelocytic leukemia (French-American-British Class M3 AML).

          7. Participants with known active central nervous system (CNS) disease.