Master Framework For Relapse or Refractory Acute Myeloid Leukemia
NCT Number: NCT06459024
Acronym: IMPACT STREAM
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myeloid Leukemia, in Relapse|Acute Myeloid Leukemia Refractory
Interventions: OTHER: Registration into the STREAM platform
Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators: Hospital Vall d'Hebron|Cyprus Institute of Neurology and Genetics|European LeukemiaNet|Fundacion Para La Investigacion Hospital La Fe|Ostedusche Hematology and Oncology Study Group|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|Time.Lex
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 4000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2032-07
Locations: ASST Spedali Civili, Brescia, BS, 25123, Italy|Azienda Ospedaliera S. Croce e Carle, Cuneo, CN, 12100, Italy|Ospedale Valduce, Como, CO, 22100, Italy|ASST Cremona, Cremona, CR, 26100, Italy|AOU Universitaria Arcispedale Sant'Anna, Ferrara, FE, 44124, Italy|IRCCS Ospedale Policlinico San Martino, Genova, GE, 16132, Italy|Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, MI, 20122, Italy|Ospedale Santa Maria della Misericordia, Perugia, PG, 06156, Italy|Ospedale Santa Maria delle Croci, Ravenna, RA, 48121, Italy|Policlinico Umberto I, Roma, RM, 00161, Italy|Ospedale infermi di Rimini, Rimini, RN, 47923, Italy|AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno, SA, 84131, Italy|AOU Città della Salute e della Scienza di Torino, Torino, TO, 10126, Italy|IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, 47014, Italy|AOU Maggiore della Carità, Novara, 28100, Italy

Summary:
This is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites

Primary Outcome Measures: The primary endpoint is to determine the overall survival of R/R AML patients, Overall survival is defined as the time from R/R diagnosis to death due to any cause., 8 years
Secondary Outcome Measures: Remission rate, Response is defined according to ELN 2022 criteria. Rates of CR, CRi, CRh and overall response (CR+CRi+CRh) as best response will be considered, 8 years|Event-free survival, Event-free survival is defined as the time from R/R diagnosis to rescue treatment failure (according to ELN 2022 definitions), relapse or death due to any cause, whichever occurs first., 8 years|Relapse free survival, Relapse-free survival is defined for patients achieving a response to rescue treatment as the time from response onset to relapse or death due to any cause, whichever occurs first., 8 years|Transplant rate, Proportion of patients undergoing transplantation, 8 years|Describe the methods for diagnosis and the treatment options offered to the patients affected by R/R AML, type and frequency of diagnostic procedures used and treatments prescribed, 8 years|Association between baseline clinical, molecular and biological parameters and clinical outcomes, Rates of CR, CRi, CRh and overall response (CR+CRi+CRh) in specific sub-populations bearing common molecular features, 8 years|To characterize potential populations that could be target for future studies/clinical trials, descriptive statistics (mean, median, frequency, range) of subpopulations characteristics, 8 years