Alvocidib Biomarker-driven Phase 2 AML Study

Official Title

Phase 2, Randomized, Biomarker-driven Study in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With an Exploratory Arm in Patients With Newly Diagnosed High-Risk AML and Exploratory Arms With Varying Levels of MCL-1 Dependence

Summary:

The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML patients with demonstrated MCL-1 dependence of ≥ 40% by mitochondrial profiling in bone marrow.

Trial Description

Primary Outcome:

  • Complete Remission (CR) rate = Percentage of patients achieving CR after Cycle 1 as defined in Stage 1 by the International Working Group Criteria and 2010 European LeukemiaNet (ELN) criteria and in Stage 2 by the 2017 ELN criteria.
Secondary Outcome:
  • Overall Survival (OS) Rate
  • Combined CR Rate = Percentage of patients achieving CR, CRi, CRp (CRp is kept in definitions for Combined CR Rate / Combined Remission Rate as Stage-1 patients were assessed by IWG criteria. CRp won't be used for assessing Stage-2 patients.)
  • Combined Response Rate = Percentage of patients achieving CR, CRi, CRp, PR
  • Rate of Stem Cell Transplantation
  • Event-Free Survival
In Stage 1 of the study, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 40% by mitochondrial profiling in bone marrow will receive treatment with ACM. In Stage 2, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 40% by mitochondrial profiling in bone marrow will be randomized 1:1 to receive either treatment with ACM or CM. In the NDHR exploratory arm, all eligible patients with newly diagnosed high-risk (NDHR) AML with MCL-1 dependence of ≥40% by mitochondrial profiling in bone marrow will receive treatment with ACM. In the MCL-1 dependency exploratory arms, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 30
  • <40% (Arm A), 15%
  • <30% (Arm B), or 0
  • <15% (Arm C) by mitochondrial profiling in bone marrow who are either in first relapse (within 24 months of CR) or have primary refractory AML (ie, no CR or CRi after 2 cycles of intensive anthracycline/cytarabine ± etoposide or cladribine induction) will receive treatment with ACM.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society