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A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients With AML

About

Brief Summary

This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Key Inclusion Criteria:

  • Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Adequate liver, renal, and cardiac function according to protocol defined criteria
  • A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention

Key Exclusion Criteria:

  • Diagnosis of either acute promyelocytic leukemia or blast chronic myelomonocytic leukemia
  • Known history of BCR-ABL alteration
  • Advanced malignant hepatic tumor [for patients receiving ven/aza combination]
  • Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery
  • Active central nervous system (CNS) involvement by AML.
  • Clinical signs/symptoms of leukostasis or WBC > 25,000 / microliter. Hydroxyurea and/or leukapheresis are permitted to meet this criterion
  • Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia
  • Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
  • For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and/or leukapheresis to control leukocytosis, prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia, or non-HMA therapy for prior myelodysplastic syndrome
  • For relapsed/refractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational < 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug
  • Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol
  • Mean corrected QT interval corrected for heart rate by Fredericia's formula (QTcF)

    480 ms on triplicate ECGs

  • Uncontrolled infection
  • Women who are pregnant or lactating
  • An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing

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Study Stats
Protocol No.
23-000452
Category
Leukemia
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05735184
For detailed technical eligibility, visit ClinicalTrials.gov.