Health Trials

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

ConditionsAMLAML With Mutated NPM1Hematologic MalignancyKMT2ArNPM1 MutationMLL RearrangementLeukemiaAcute Myeloid LeukemiaLeukemia, MyeloidLeukemia, Myeloid, AcuteAcute LeukemiaNeoplasms by Histologic Type
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKura Oncology, Inc.

About this trial

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.

Eligibility criteria

Qualifiers

Has been diagnosed with relapsed/refractory AML.

Has a documented NPM1 mutation or KMT2A rearrangement.

Has a documented FLT3 mutation (cA-3 only).

Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.

Disqualifiers

Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.

Has clinically active central nervous system leukemia.

Has an active and uncontrolled infection.

Has a mean corrected QT interval (QTcF) > 480ms.

Trial design

Treatments tested in this trial

  • Ziftomenib
  • Fludarabine
  • Idarubicin
  • Cytarabine
  • Gilteritinib
  • Granulocyte colony-stimulating factor

Treatment groups

171 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kura Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov