A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Inclusion Criteria:

Must have adequate coagulation, hematology, kidney, and liver function, per protocol.
Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML)
Meet the following disease activity criteria:
an established, confirmed diagnosis of AML by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3; and
an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
If male participant is sexually active, he must agree from day 1 through 6 months after the last dose of alvocidib or 90 days after the last dose of venetoclax, whichever is longer, to practice the protocol-specified protection.

Exclusion Criteria:

History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ.
Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
History of previous enrollment in Studies NCT02993523 or NCT03069352.
History of exposure to alvocidib or any other cyclin-dependent kinase 9 (CDK9) inhibitor.
History of Tumor Lysis Syndrome (TLS) due to previous exposure to venetoclax.