A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT03441555 |
Recruitment Status :
Completed
First Posted : February 22, 2018
Last Update Posted : February 1, 2022
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Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia (AML) | Drug: Venetoclax Drug: Alvocidib | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1b Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia |
Actual Study Start Date : | May 30, 2018 |
Actual Primary Completion Date : | January 25, 2021 |
Actual Study Completion Date : | January 25, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: Venetoclax
tablet, oral
Other Name: ABT-199 Drug: Alvocidib Intravenous
Other Name: Flavopiridol |
- Tmax of venetoclax [ Time Frame: Approximately 32 days after first dose of study drug ]Time to maximum plasma concentration (Tmax) of venetoclax
- Clearance of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Clearance (CL) of alvocidib
- AUC0-∞ of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of alvocidib
- Cmax of Venetoclax [ Time Frame: Approximately 32 days after first dose of study drug ]Maximum plasma concentration (Cmax) of venetoclax
- Half-life (t1/2) of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Half-life (t1/2) of alvocidib
- AUC0-24 Post-dose of Venetoclax [ Time Frame: Approximately 32 days after first dose of study drug ]Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
- Cmax of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Maximum plasma concentration (Cmax) of alvocidib.
- AUCt Post-dose of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose alvocidib.
- Dose Escalation Phase: Recommended Phase 2 dose (RPTD) for Venetoclax and Alvocidib [ Time Frame: Minimum first cycle of dosing (up to 28 days) ]RPTD will be determined using available safety and pharmacokinetics data upon completion of the dose escalation phase.
- Complete Response (CR) Rate [ Time Frame: Up to approximately 8 months ]CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.
- Combined CR Rate [ Time Frame: Up to approximately 8 months ]Combined CR rate is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 18 months ]ORR is defined as the proportion of participants with documented partial response (PR) or better based on IWG criteria.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441555
United States, California | |
USC Norris Cancer Center /ID# 170844 | |
Los Angeles, California, United States, 90033 | |
UC Irvine /ID# 201093 | |
Orange, California, United States, 92868 | |
University of California, Davis Comprehensive Cancer Center /ID# 170799 | |
Sacramento, California, United States, 95817 | |
United States, Florida | |
Sylvester Comprehensive Cancer /ID# 170761 | |
Miami, Florida, United States, 33136-1002 | |
United States, Indiana | |
Indiana Blood & Marrow Transpl /ID# 170793 | |
Indianapolis, Indiana, United States, 46237 | |
United States, New York | |
NYU Langone Medical Center /ID# 201559 | |
New York, New York, United States, 10016-6402 | |
Weill Cornell Medical College /ID# 170800 | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Duke University Medical Center /ID# 170842 | |
Durham, North Carolina, United States, 27710-3000 | |
United States, Pennsylvania | |
University of Pittsburgh Medic /ID# 170790 | |
Pittsburgh, Pennsylvania, United States, 15261 | |
Germany | |
Universitaetsklinikum Dresden /ID# 168636 | |
Dresden, Germany, 01307 | |
Univ Klinik Eppendorf Hamburg /ID# 168633 | |
Hamburg, Germany, 20246 | |
United Kingdom | |
University Hospital of Wales /ID# 202302 | |
Cardiff, United Kingdom, CF14 4EN | |
Ninewells Hospital /ID# 202304 | |
Dundee, United Kingdom, DD1 9SY | |
St. James University Hospital /ID# 202303 | |
Leeds, United Kingdom, LS9 7TF |
Study Director: | AbbVie Inc. | AbbVie |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT03441555 |
Other Study ID Numbers: |
M16-186 2017-002531-42 ( EudraCT Number ) |
First Posted: | February 22, 2018 Key Record Dates |
Last Update Posted: | February 1, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Cancer Acute Myeloid Leukemia (AML) relapsed Acute Myeloid Leukemia refractory Acute Myeloid Leukemia |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Venetoclax Alvocidib |
Antineoplastic Agents Growth Inhibitors Growth Substances Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |