Testing ziftomenib combinations in relapsed acute myeloid leukemia
Tests ziftomenib with other drugs in adults with returning acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Key facts
- Where
- Bologna, Ravenna, and Rome, ItalySee the 3 sites
- Phase
- Phase 1
Where in Italy
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kura Oncology, Inc.
- Trial code
- NCT06001788EU 2023-510288-37-00
- Record updated
- 20 August 2026
- Original description
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.Read full original descriptionShow less
Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia
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.
Inclusion: 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; Has adequate hepatic and renal function as defined per protocol; Has an ejection fraction above a protocol defined limit; Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure; Has agreed to use contraception as defined per protocol.
Exclusion: Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy <14 days or within 5 drug half-lives prior to the first dose of study intervention; Has had major surgery within 4 weeks prior to the first dose of study intervention; Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria; Has an active and uncontrolled infection; Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease; Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD; Has a mean corrected QT interval (QTcF) > 480ms; Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia; Has clinically active central nervous system leukemia; Participant is pregnant or lactating.