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Phase 1 study of venetoclax/azacitidine or venetoclax in combination with ziftomenib (KO-539) or standard induction cytarabine/ daunorubicin (7+3) chemotherapy in combination with ziftomenib for the treatment of patients with acute myeloid leukemia

Primary:
To determine the safety and tolerability of ziftomenib combined with SOC treatments in adults
with newly diagnosed NPM1-m or KMT2A-r AML and for ziftomenib combined with SOC treatments

To determine the antileukemic activity of ziftomenib combined with SOC treatments in adults
with newly diagnosed NPM1-m or KMT2A-r AML and for ziftomenib combined with SOC treatments in NPM1-m or KMT2A-r patients with relapsed or refractory AML in NPM1-m or KMT2A-r patients with relapsed or refractory AML

Secondary:
To evaluate survival, disease control outcomes and additional markers of antileukemic activity for ziftomenib combined with SOC treatments in adults with newly diagnosed NPM1-m or KMT2A-r AML and for ziftomenib combined with SOC treatments in NPM1-m or KMT2A-r patients with relapsed or refractory AML

Characterize the pharmacokinetics of ziftomenib and metabolites when administered in combination with SOC treatments in adults with newly diagnosed NPM1-m or KMT2A-r AML and for ziftomenib combined with SOC treatments in NPM1-m or KMT2A-r patients with relapsed or refractory AML
To evaluate the potential drug interaction of ziftomenib on venetoclax (i.e., potential inhibition
of CYP3A4 metabolism of venetoclax by ziftomenib)

Protocol Number: 022305
Phase: Phase I
Applicable Disease Sites: Myeloid and Monocytic Leukemia
Drugs Involved: AZACITIDINE(Vidaza)
Venetoclax (ABT-199)
Ziftomenib
Principal Investigator: Neil Palmisiano
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.