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Back|NCT06001788Recruiting
Official Title

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

Phase
Phase 1
Sponsor
Kura Oncology, Inc.
Enrollment
171
Timeline
Feb 2024 → Aug 2027
About This Study

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

Inclusion Criteria

  • 1Has been diagnosed with relapsed/refractory AML.
  • 2Has a documented NPM1 mutation or KMT2A rearrangement.
  • 3Has a documented FLT3 mutation (cA-3 only).
  • 4Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
  • 5Has adequate hepatic and renal function as defined per protocol.
  • 6Has an ejection fraction above a protocol defined limit.
  • 7Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
  • 8Has agreed to use contraception as defined per protocol.

Exclusion Criteria

  • 1Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
  • 2Has clinically active central nervous system leukemia.
  • 3Has an active and uncontrolled infection.
  • 4Has a mean corrected QT interval (QTcF) \> 480ms.
  • 5Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
  • 6Has 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.
  • 7Has had major surgery within 4 weeks prior to the first dose of study intervention.
  • 8Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
  • 9Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
  • 10Participant is pregnant or lactating.

Locations

44 sites participating in this study

Emory Healthcare - The Emory Clinic

Atlanta, Georgia 30322

Recruiting

Gigi Stoneback

gissela.blanco.stoneback@emory.edu

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

Recruiting

USC Norris Comprehensive Cancer Center

Los Angeles, California 90089

Recruiting

Christine Duran

duran_c@med.usc.edu323-865-0371
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →