Clinical Trial

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

Study acronym: IMPACT-AML
Recruiting Phase 3
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Summary
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)
Protocol Amendment History 1 change
notable Trial sites expanded: 37 -> 47 locations 2026-04-09
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 Acute Myeloid Leukemia, Relapse/Recurrence
Enrollment 339 participants
Start Date 2025-02-27
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-14