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

Phase 1b Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia

An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).

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.