A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT ID: NCT03441555
Last Updated: 2022-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2018-05-30
2021-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venetoclax + Alvocidib
Venetoclax administered orally once daily (QD) and Alvocidib administered as an intravenous infusion on Days 1, 2, and 3 for all 28-day treatment cycles. Different combinations of dose levels for venetoclax and alvocidib may be explored.
Venetoclax
tablet, oral
Alvocidib
Intravenous
Interventions
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Venetoclax
tablet, oral
Alvocidib
Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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Related Links
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Other Identifiers
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2017-002531-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-186
Identifier Type: -
Identifier Source: org_study_id
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