IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

Study acronym: IMPACT-AML
StatusRecruiting
PhasePhase 3
Started

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Record History

  1. Site details revised at 4 of 47 sitesv16
  2. Site details revised at 5 of 47 sitesv15
  3. Trial sites expanded: 37 → 47 locationsv14
  4. Site details revised at 1 of 37 sitesv13
  5. Study sites: 34 to 37v12
Show 10 earlier versionsHide 10 earlier versions
  1. Site details revised at 4 of 34 sitesv11
  2. Site details revised at 2 of 34 sitesv10
  3. Site details revised at 3 of 34 sitesv9
  4. Site details revised at 5 of 34 sitesv8
  5. Site details revised at 1 of 34 sitesv7
  6. Study sites: 33 to 34v6
  7. Study sites: 22 to 33v5
  8. Site details revised at 1 of 22 sitesv4
  9. Site details revised at 1 of 22 sitesv3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2025 to Feb 27, 2025
    • Site details revised at 22 of 22 sites
    v2
  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.
This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)
Trial Details
NCT Number NCT06713837
Lead Sponsor Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Collaborators: Hospital Vall d'Hebron, Cyprus Institute of Neurology and Genetics, European Leukemia Net, Fundacion Para La Investigacion Hospital La Fe, Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V., Ospedale Pediatrico Bambin Gesù, Czech Lymphoma Study Group, Charite University, Berlin, Germany, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León, University of Bologna, Hannover Medical School, German Society for Pediatric Oncology and Hematology GPOH gGmbH, Toscana Life Sciences Sviluppo s.r.l., Lithuanian University of Health Sciences, Gruppo Italiano Malattie EMatologiche dell'Adulto, TIMELEX
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Relapse/Recurrence
Related terms Disease, Leukemia, Myeloid, Acute, Recurrence
Enrollment 339 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov