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)
Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria
1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022
Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician
Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice
Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC) (e.g. hypersensitivity, allergy, organ failure precluding treatment)
Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization
Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Lead sponsor
Hospital Vall d'Hebron
Collaborator
Cyprus Institute of Neurology and Genetics
Collaborator
European Leukemia Net
Collaborator
Fundacion Para La Investigacion Hospital La Fe
Collaborator
Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V.
Collaborator
Ospedale Pediatrico Bambin Gesù
Collaborator
Czech Lymphoma Study Group
Collaborator
Charite University, Berlin, Germany
Collaborator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborator
University of Bologna
Collaborator
Hannover Medical School
Collaborator
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Collaborator
Toscana Life Sciences Sviluppo s.r.l.
Collaborator
Lithuanian University of Health Sciences
Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborator
TIMELEX
Collaborator