Alvocidib Biomarker-driven Phase 2 AML Study

  • STATUS
    Not Recruiting
  • participants needed
    79
  • sponsor
    Tolero Pharmaceuticals, Inc.
Updated on 12 June 2021
Investigator
Judy Costas, BSN
Primary Contact
East Carolina University (2.5 mi away) Contact
+32 other location
remission
cytarabine
flow cytometry
ejection fraction
gilbert's syndrome
mitoxantrone
neoadjuvant therapy
gemtuzumab
acute promyelocytic leukemia
cladribine
anthracyclines
hemolysis

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.

Description

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.

Details
Condition Acute myeloid leukemia
Treatment cytarabine, Mitoxantrone, alvocidib
Clinical Study IdentifierNCT02520011
SponsorTolero Pharmaceuticals, Inc.
Last Modified on12 June 2021

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