Health Trials

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

ConditionsAcute Myeloid LeukemiaMixed Lineage Leukemia Gene MutationRefractory AMLAML With Mutated NPM1Acute Myeloid Leukemia RecurrentAcute Myeloid Leukemia, in RelapseNPM1 MutationKMT2ArMyeloid SarcomaNucleophosmin 1-mutated Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKura Oncology, Inc.

About this trial

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.

This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.

The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.

Eligibility criteria

Qualifiers

Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML

Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Adequate liver, renal, and cardiac function according to protocol defined criteria

Disqualifiers

Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia

Known history of BCR-ABL alteration

Advanced malignant hepatic tumor

Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery

Trial design

Treatments tested in this trial

  • Ziftomenib
  • Venetoclax
  • Azacitidine
  • Daunorubicin
  • Cytarabine
  • Quizartinib

Treatment groups

420 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Sponsors and collaborators

Kura Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov