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Completed

NCT Number: NCT03441555

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

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).

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitaetsklinikum Dresden /ID# 168636, Dresden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venetoclax

Drug

tablet, oral

Other names: ABT-199

alvocidib

Drug

Intravenous

Other names: Flavopiridol

Primary outcomes

  1. Tmax of venetoclax

    Time frame: Approximately 32 days after first dose of study drug

    Time to maximum plasma concentration (Tmax) of venetoclax

  2. Clearance of Alvocidib

    Time frame: Approximately 32 days after first dose of study drug

    Clearance (CL) of alvocidib

  3. 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

  4. Cmax of Venetoclax

    Time frame: Approximately 32 days after first dose of study drug

    Maximum plasma concentration (Cmax) of venetoclax

  5. Half-life (t1/2) of Alvocidib

    Time frame: Approximately 32 days after first dose of study drug

    Half-life (t1/2) of alvocidib

  6. 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.

  7. Cmax of Alvocidib

    Time frame: Approximately 32 days after first dose of study drug

    Maximum plasma concentration (Cmax) of alvocidib.

  8. 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.

  9. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Sumitomo Pharma America, Inc.

Registry information

Official study title

Phase 1b Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2018
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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