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Studies

Observational Recruiting

NCT06459024 on ClinicalTrials.gov

Master Framework For Relapse or Refractory Acute Myeloid Leukemia

Official title: Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes

  • 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 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
  • Enrollment: 4000 (Estimated)
  • Study start: 2024-06-28 (Actual)
  • Primary completion: 2032-07-01 (Estimated)
  • Study completion: 2032-07-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief 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

Conditions

  • Acute Myeloid Leukemia, in Relapse
  • Acute Myeloid Leukemia Refractory

Intervention / Treatment

  • Other: Registration into the STREAM platform

Primary Outcome Measures

  • The primary endpoint is to determine the overall survival of R/R AML patients (8 years)
    Overall survival is defined as the time from R/R diagnosis to death due to any cause.

Countries

Germany, Italy, Jordan, Lithuania, Poland, Romania, Spain

Locations and Investigators

  • University Hospital Aachen, Aachen, Germany (Recruiting)
    • Martina Crysandt, MD
  • University Hospital Greifswald, Greifswald, Germany (Recruiting)
    • Adrian Schwarzer, MD
  • University Hospital Halle, Halle, Germany (Recruiting)
    • Judith Schaffrath, MD
  • University Hospital of Rostock, Rostock, Germany (Recruiting)
    • Christian Junghanß, MD
  • Policlinico Sant'Orsola-Malpighi, Bologna, Italy (Recruiting)
    • Cristina Papayannidis, MD
  • Ospedale "A. Perrino", Brindisi, Italy (Recruiting)
    • Marina Aurora Urbano, MD
  • ASST Spedali Civili, Brescia, Italy (Recruiting)
    • Erika Borlenghi, MD
  • Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy (Recruiting)
    • Daniele Mattei, MD
  • Ospedale Valduce, Como, Italy (Recruiting)
    • Mauro Turrini, MD
  • ASST Cremona, Cremona, Italy (Recruiting)
    • Alfredo Molteni, MD
  • AOU Universitaria Arcispedale Sant'Anna, Ferrara, Italy (Recruiting)
    • Gian Matteo Rigolin, MD
  • IRCCS Ospedale Policlinico San Martino, Genova, Italy (Recruiting)
    • Matteo Emidio Dragani, MD
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy (Recruiting)
    • Nicola Stefano Fracchiolla, MD
  • ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy (Recruiting)
    • Rosa Greco, MD
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo, Italy (Recruiting)
    • Antonino Mulè, MD
  • Presidio Ospedaliero "Santo Spirito", Pescara, Italy (Not yet recruiting)
    • Prassede Salutari, MD
  • Ospedale Santa Maria della Misericordia, Perugia, Italy (Recruiting)
    • Maria Paola Martelli, MD
  • Ospedale Santa Maria delle Croci, Ravenna, Italy (Recruiting)
    • Giovanni Marconi, MD
  • Fondazione Policlinico Tor Vergata, Roma, Italy (Recruiting)
    • Adriano Venditti, MD
  • Policlinico Umberto I, Roma, Italy (Recruiting)
    • Saveria Capria, MD
  • Policlinico Universitario Fondazione Agostino Gemelli, Roma, Italy (Recruiting)
    • Patrizia Chiusolo, MD
  • Ospedale Sant'Andrea, Roma, Italy (Recruiting)
    • Agostino Tafuri, MD
  • Ospedale infermi di Rimini, Rimini, Italy (Recruiting)
    • Anna Maria Mianulli, MD
  • AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy (Recruiting)
    • Bianca Serio, MD
  • AOU Città della Salute e della Scienza di Torino, Torino, Italy (Recruiting)
    • Ernesta Audisio, MD
  • AO Ordine Mauriziano, Torino, Italy (Recruiting)
    • Alessandro Cignetti, MD
  • IOV Istituto Oncologico Veneto, Castelfranco Veneto, Italy (Recruiting)
    • Alessandra Sperotto, MD
  • ASST Valle Olona, Busto Arsizio, Italy (Recruiting)
    • Elisabetta Todisco, MD
  • Azienda Ospedaliero Universitaria Delle Marche, Ancona, Italy (Recruiting)
    • Lorenzo Brunetti, MD
  • AOU Careggi, Florence, Italy (Recruiting)
    • Francesco Mannelli, MD
  • IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy (Recruiting)
    • Maria Benedetta Giannini, MD
  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli, Naples, Italy (Recruiting)
    • Mario Annunziata, MD
  • Azienda Ospeldaliera Universitaria Federico II, Naples, Italy (Recruiting)
    • Fabrizio Pane, MD
  • AOU Maggiore della Carità, Novara, Italy (Recruiting)
    • Monia Lunghi, MD
  • Azienda Ospedale-Università Padova, Padova, Italy (Recruiting)
    • Federica Lessi, MD
  • Ospedale San Bortolo, Vicenza, Italy (Recruiting)
    • Davide Facchinelli, MD
  • King Hussein Cancer Center, Amman, Jordan (Recruiting)
    • Zaid Abdel Rahman, MD
  • The Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Kaunas, Lithuania (Recruiting)
    • Rolandas Gerbutavičius, MD
  • University Clinical Center in Gdańsk, Gdansk, Poland (Recruiting)
    • Karolina Bełdzińska-Gądek, MD
  • Fundeni Clinical Institute, Bucharest, Romania (Recruiting)
    • Daniel Coriu, MD
  • University Hospital La Fe, Valencia, Spain (Recruiting)
    • Pau Montesino, MD

Study Officials