Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06001788

RecruitingPhase 1

Sponsor: Kura Oncology, Inc.

Conditions: AML, AML With Mutated NPM1, Hematologic Malignancy, KMT2Ar, NPM1 Mutation

Interventions: Ziftomenib, Fludarabine, Idarubicin, Cytarabine, Gilteritinib

Countries: United States, Italy, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.
* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
* 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 active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
* Participant is pregnant or lactating.
Locations (45)
  • Gilbert, Arizona, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • San Francisco, California, United States
  • Denver, Colorado, United States
  • New Haven, Connecticut, United States
  • Atlanta, Georgia, United States
  • Augusta, Georgia, United States
  • Chicago, Illinois, United States
  • Maywood, Illinois, United States
  • Springfield, Illinois, United States
  • Iowa City, Iowa, United States
  • Kansas City, Kansas, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Detroit, Michigan, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Hackensack, New Jersey, United States
  • Buffalo, New York, United States
  • Lake Success, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Stony Brook, New York, United States
  • Charlotte, North Carolina, United States
  • Cleveland, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Allentown, Pennsylvania, United States
  • + 15 more on CT.gov