Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, Mixed Lineage Acute Leukemia, Mixed Lineage Leukemia Gene Mutation, Mixed Phenotype Acute Leukemia, Refractory AML, AML With Mutated NPM1, Acute Myeloid Leukemia Recurrent, Acute Myeloid Leukemia, in Relapse, NPM1 Mutation, KMT2Ar, Myeloid Sarcoma, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Leukemia, Biphenotypic, Acute, Acute Disease, Cytarabine, Azacitidine, Daunorubicin, Venetoclax, Ziftomenib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA - Bowyer Oncology Center accepting new patients
    Los Angeles California 90095 United States
  • USC University of Southern California / Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kura Oncology, Inc.
ID
NCT05735184
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 212 study participants
Last Updated