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Alvocidib for AML after Venetoclax Combination Tx

A Phase 2, Open-label, Randomized, Two-stage Clinical Study of Alvocidib in Patients with Relapsed/Refractory Acute Myeloid Leukemia Following Treatment with Venetoclax Combination Therapy

  • Clinical Trial Information

    Trial Contact: Walton, Sherri

    Trial Phone: 321.841.1907

  • IRB No: WIRB 20191962

    Protocol Abbrev: TPI-ALV-202

    Principal Investigator: Julio J. Hajdenberg, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: TPI-ALV-202

    Treatment: ARM 1: Alvocidib + Low-dose cytarabine (ALDAC); treatment will be given every 28 days ARM 2: Alvocidib (ALV); treatment will be given every 28 days

    Therapies Involved: Chemotherapy;Oncology: 2nd line;Oncology: 3rd line/Refractory

    ClinicalTrials.gov ID: NCT03969420

  • Objective

    This study will evaluate the safety and efficacy of alvocidib in patients with AML who have either relapsed from or are refractory to venetoclax in combination with azacytidine or decitabine.

  • Key Eligibility

    Adult patients must have refractory or relapsed AML after initial
    induction therapy with venetoclax in combination with azacytidine or decitabine