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ACT001 for the Treatment of Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Lead sponsor: Nationwide Children's Hospital to Nationwide Children's Hospital Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 75 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 18 of 20 sites
    • Study description expanded, about 2 words
  2. Site details revised at 2 of 20 sitesv15
  3. Eligibility criteria shortened, about 19 wordsv14
  4. Site contacts updated at 1 of 20 sitesv13
  5. Study sites: 19 to 20v12
Show 10 earlier versionsHide 10 earlier versions
  1. Site details revised at 1 of 19 sitesv11
  2. Site details revised at 1 of 19 sitesv10
  3. Site details revised at 1 of 19 sitesv9
  4. Site details revised at 1 of 19 sitesv8
  5. Study sites: 18 to 19v7
  6. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 18 of 18 sites
    v6
  7. Re-verified, no change to tracked fieldsv5
  8. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Jul 2025 to Jul 10, 2025
    • Eligibility criteria expanded, about 12 words
    • Site contacts updated at 18 of 18 sites
    v4
  9. Re-verified, no change to tracked fieldsv3
  10. Eligibility criteria revisedv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase II open-label study to investigate the safety and efficacy of ACT001 in patients with DIPG and H3K27-altered HGG.
Trial Details
NCT Number NCT06838676
Lead Sponsor Nationwide Children's Hospital
Collaborators: Accendatech USA Inc.
Conditions
(from sponsor)		 Diffuse Intrinsic Pontine Gliomas (DIPG), Progressive DIPG, Refractory DIPG, Recurrent DIPG, H3K27-altered High Grade Glioma
Related terms Diffuse Intrinsic Pontine Glioma, Glioma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov