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

Status: Active

Description

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).

Eligibility Criteria

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
  • - 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.

Locations & Contacts

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Approved
Contact: Christine Duran
Phone: 323-865-0371
Email: Duran_C@med.usc.edu
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Abbvie

Trial IDs

Primary ID M16-186
Secondary IDs NCI-2018-00730, 2017-002531-42
Clinicaltrials.gov ID NCT03441555