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Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 8, 2024 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Apr 2024 to Apr 2025v8 Show 6 more changesShow less
    • Primary endpoints: 2 to 1
    • Interventions: Gemtuzumab Ozogamicin (Drug), Glasdegib (Drug) to Gemtuzumab Ozogamicin (Drug)
    • Eligibility criteria revised
    • Study description shortened, about 12 words
    • Study arms: 2 to 1
    • Study title shortened, about 2 words
  2. Primary completion date: Apr 2023 to Apr 2024v7
  3. Re-verified, no change to tracked fieldsv6
  4. Study sites: 7 to 48v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of Oct 2020 to Sep 24, 2020
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jun 2020 to Oct 2020
    • Primary completion date: Dec 2022 to Apr 2023
    • Study completion date: Dec 2026 to Apr 2027
    v3
  2. Start date: Feb 1, 2020 to Jun 2020
    • Primary completion date: Oct 1, 2022 to Dec 2022
    • Study completion date: Oct 1, 2026 to Dec 2026
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.
Trial Details
NCT Number NCT04168502
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 414 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov