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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2026 → Dec 2026
See other at-risk trials from Kura Oncology, Inc.

Record History

  1. Primary completion pushed from Aug 2026 to Dec 2026v19
  2. Study sites: 44 to 45v18
  3. Site contacts updated at 1 of 44 sitesv17
  4. Study sites: 43 to 44v16
  5. Study sites: 41 to 43v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 25 to 41 Eligibility criteria shortened, about 1 wordv14 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 14 to 25v13
  3. Study sites: 13 to 14v12
  4. Study sites: 9 to 13v11
  5. Site contacts updated at 1 of 9 sitesv10
  6. Study sites: 7 to 9v9
  7. Study sites: 6 to 7v8
  8. Study sites: 5 to 6v7
  9. Study sites: 2 to 5v6
  10. Start date changed from estimate of Jan 2024 to Feb 22, 2024v5
  11. Study sites: 1 to 2v4
  12. Start date: Dec 2023 to Jan 2024 Secondary endpoints: details revised at 2 of 20 entriesv3 Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 20 entries
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06001788
Lead Sponsor Kura Oncology, Inc.
Conditions AML, AML With Mutated NPM1, Hematologic Malignancy, KMT2Ar, NPM1 Mutation, MLL Rearrangement, Leukemia, Acute Myeloid Leukemia +4 more
Enrollment 171 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov