Health Trials

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

Locations

45
Italy
IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola40138, Bologna Italy
Ospedale Santa Maria delle Croci48121, Ravenna Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS00168, Roma Italy
Spain
Hospital Universitari Vall d'Hebron08035, Barcelona Spain

Sponsors and collaborators

Kura Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov