Status:
COMPLETED
A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 preliminar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03441555
Start Date
May 30 2018
End Date
January 25 2021
Last Update
February 1 2022
Active Locations (14)
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1
USC Norris Cancer Center /ID# 170844
Los Angeles, California, United States, 90033
2
UC Irvine /ID# 201093
Orange, California, United States, 92868
3
University of California, Davis Comprehensive Cancer Center /ID# 170799
Sacramento, California, United States, 95817
4
Sylvester Comprehensive Cancer /ID# 170761
Miami, Florida, United States, 33136-1002