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Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 years 1 month later Jan 2027 → Mar 2033
See other at-risk trials from PedAL BCU, LLC

Record History

  1. Primary and study completion pushed from Jan 2027 to Mar 2033 Eligibility criteria shortened, about 157 words · Secondary endpoints: details revised at 3 of 18 entries · Site details revised at 10 of 20 sites Show 3 more changesShow less
    • Eligibility criteria shortened, about 157 words
    • Secondary endpoints: details revised at 3 of 18 entries
    • Site details revised at 10 of 20 sites
  2. Study sites: 18 to 20v10
  3. Study sites: 17 to 18v9
  4. Study sites: 15 to 17v8
  5. Study sites: 5 to 15 Start date changed from estimate of Mar 2025 to Mar 18, 2025v7 Show 1 more changeShow less
    • Start date changed from estimate of Mar 2025 to Mar 18, 2025
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Start date: Feb 2025 to Mar 2025v6 Show 2 more changesShow less
    • Study sites: 0 to 5
    • Start date: Feb 2025 to Mar 2025
  2. Start date: Nov 2024 to Feb 2025 Primary and study completion dates: Oct 2026 to Jan 2027v5 Show 1 more changeShow less
    • Primary and study completion dates: Oct 2026 to Jan 2027
  3. Start date: Sep 2024 to Nov 2024 Primary and study completion dates: Sep 2026 to Oct 2026v4 Show 1 more changeShow less
    • Primary and study completion dates: Sep 2026 to Oct 2026
  4. Start date: Jun 2024 to Sep 2024 Primary and study completion dates: Aug 2027 to Sep 2026v3 Show 1 more changeShow less
    • Primary and study completion dates: Aug 2027 to Sep 2026
  5. Eligibility criteria expanded, about 27 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
PedAL BCU, LLC
3 trials monitored
See 1 trial at risk
Leukemia
2,566 trials monitored
See 143 trials at risk
The primary objective of the trial is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK).
Trial Details
NCT Number NCT06376162
Lead Sponsor PedAL BCU, LLC
Collaborators: Kura Oncology
Conditions Relapsed/Refractory KMT2A-r Acute Leukemia, Relapsed/Refractory NUP98-r Acute Leukemia, Relapsed/Refractory NPM1-m Acute Leukemia
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov