A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 2 entries Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 8 participants (planned 18)
    • Eligibility criteria expanded, about 25 words
    • Site details revised at 7 of 7 sites
  2. Start date: Jun 26, 2023 to Oct 25, 2023
    • Primary and study completion pushed from Feb 2027 to Apr 21, 2027
    v13
  3. Enrollment target: 36 to 18v12
  4. Primary and study completion dates: Feb 2026 to Feb 2027v11
  5. Primary and study completion dates: Feb 2025 to Feb 2026
    • Site contacts updated at 1 of 7 sites
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Site contacts updated at 1 of 7 sites
    • Eligibility criteria expanded, about 1 word
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Eligibility criteria expanded, about 7 wordsv7
  4. 2 versions Re-verified since Jul 14, 2023, no change to tracked fieldsv5-v6
  5. Start date: Apr 14, 2023 to Jun 26, 2023v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2023 to Apr 14, 2023
    • Site details revised at 7 of 7 sites
    v3
  7. Start date: Mar 2023 to Apr 2023v2
  1. Study First Submitted
  • 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 researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations. The researchers will also look for the highest dose of the combination of gilteritinib with ivosidenib or enasidenib that causes few or mild side effects. When the highest safe dose is found, they will test that dose in new groups of participants.
Trial Details
NCT Number NCT05756777
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Astellas Pharma US, Inc.
Conditions
(from sponsor)		 Acute Myeloid Leukemia (AML)
Related terms Leukemia, Myeloid, Acute
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov