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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

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).

Key facts

Study ID

NCT03441555

Run by

AbbVie

People needed

36

Starts

2018-05-30

Expected to finish

2021-01-25

Last updated by the study team

2022-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC Norris Cancer Center /ID# 170844 — Los Angeles, California, United States
• UC Irvine /ID# 201093 — Orange, California, United States
• University of California, Davis Comprehensive Cancer Center /ID# 170799 — Sacramento, California, United States
• Sylvester Comprehensive Cancer /ID# 170761 — Miami, Florida, United States
• Indiana Blood & Marrow Transpl /ID# 170793 — Indianapolis, Indiana, United States
• NYU Langone Medical Center /ID# 201559 — New York, New York, United States
• Weill Cornell Medical College /ID# 170800 — New York, New York, United States
• Duke University Medical Center /ID# 170842 — Durham, North Carolina, United States
• University of Pittsburgh Medic /ID# 170790 — Pittsburgh, Pennsylvania, United States
• Universitaetsklinikum Dresden /ID# 168636 — Dresden, Germany
• Univ Klinik Eppendorf Hamburg /ID# 168633 — Hamburg, Germany
• University Hospital of Wales /ID# 202302 — Cardiff, United Kingdom
• Ninewells Hospital /ID# 202304 — Dundee, United Kingdom
• St. James University Hospital /ID# 202303 — Leeds, United Kingdom

Full record on ClinicalTrials.gov

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