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Taking people in ItalyPhase 3

Tests stem cell transplant timing for high-risk myelodysplastic syndromes in adults

Compares transplant right away with azacitidine or chemotherapy first, in adults with high-risk MDS.

Plain-language title generated from the registry record
Registry title: Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)

Key facts

Where
Alexandria, Ancona, Ascoli Piceno, Bari, Bologna, Brescia, Brindisi, Castelfranco Veneto, Catania, Cuneo, Ferrara, Foggia, Latina, Lecce, Mestre - Venezia, Milan, Modena, Monza, Naples, Palermo, Pescara, Piacenza, Pisa, Reggio Calabria, Reggio Emilia, Rimini, Roma, Rome, Salerno, Sassari, Siena, Tricase, Turin, Udine, Verona, and Viterbo, ItalySee the 46 sites
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Source: NCT04184505, who can take part

Where in Italy

  • Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare ArrigoAlexandria, ItalyTaking people
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAncona, ItalyTaking people
  • Azienda Sanitaria Territoriale di Ascoli PicenoAscoli Piceno, ItalyTaking people
  • University Hospital Consorziale PoliclinicoBari, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
  • Azienda Sanitaria Locale BrBrindisi, ItalyTaking people
  • Istituto Oncologico VenetoCastelfranco Veneto, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
  • Azienda Ospedaliera Santa Croce E CarleCuneo, ItalyTaking people
  • University Hospital Of FerraraFerrara, ItalyTaking people
  • Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
  • Ospedale Santa Maria Goretti LatinaLatina, ItalyTaking people
  • Ospedale Vito Fazzi LecceLecce, ItalyTaking people
  • ULSS3 SERENISSIMA - Ospedale dell'Angelo di MestreMestre - Venezia, ItalyTaking people
  • ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
  • Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
  • Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
  • Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyTaking people
  • Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyTaking people
  • Azienda Sanitaria Locale di PescaraPescara, ItalyTaking people
  • Azienda Unita Sanitaria Locale Di PiacenzaPiacenza, ItalyTaking people
  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
  • Grande Ospedale Metropolitano Bianchi Melacrino MorelliReggio Calabria, ItalyTaking people
  • Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
  • Azienda Unita Sanitaria Locale Della RomagnaRimini, ItalyTaking people
  • Ospedale S. Eugenio, ASL Roma 2Roma, ItalyTaking people
  • Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
  • Azienda Ospedaliera S Giovanni AddolorataRome, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyTaking people
  • I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
  • San Camillo Forlanini HospitalRome, ItalyTaking people
  • Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'AragonaSalerno, ItalyTaking people
  • Azienda Sanitaria Locale Di SalernoSalerno, ItalyTaking people
  • Azienda Ospedaliero-Universitaria di SassariSassari, ItalyTaking people
  • Azienda Ospedaliera Universitaria SeneseSiena, ItalyTaking people
  • Pia Fondazione Di Culto E Religione Card G PanicoTricase, ItalyTaking people
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
  • Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
  • Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyTaking people
  • Belcolle HospitalViterbo, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Gruppo Italiano Malattie EMatologiche dell'Adulto
Trial code
NCT04184505EU 2023-510515-19-00
Record updated
29 April 2025
Original description
Open-label, randomized multicenter phase III non-inferiority studyRead full original descriptionShow less

Prospective Randomized Study on the Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-myelodysplastic Syndromes, Performed Upfront or Preceded by Azacitidine or Conventional Chemotherapy According to the BM-blast Proportion

Open-label, randomized multicenter phase III non-inferiority study

Inclusion: Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, and IPSS-R intermediate to very-high; Age 18-70 years; Previously untreated for HR-MDS; HSCT - eligible; Life expectancy ≥3 months; Signed written informed consent according to ICH/EU/GCP and national local laws; Eastern Cooperative Oncology Group Performance Status Grade of 0-2.

Exclusion: concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma); pregnant or lactating or potentially fertile (both males and females), who have not agreed to avoid pregnancy during the trial period; Women of childbearing potential and men must agree to use effective contraception during and up to 3 months after treatment with azacitidine; prior Treatments:; prior investigational drugs (within 30 days); radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months; growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days; androgenic hormones during the previous 14 days; prior transplantation or cytotoxic therapy, including azacitidine, AZA or chemotherapy, administered to treat MDS (a previous treatment with Lenalidomide is admitted, provided that lenalidomide had been stopped at least 60 days before enrolment); severe renal, cardiac, liver or lung impairment; HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis; clinically relevant neurological or psychiatric diseases; hypersensitivity (known or suspected) to AZA; Acute myeloid leukaemia with >20% blasts in BM or peripheral blood (PB).

ClinicalTrials.gov NCT04184505 · EU CTIS 2023-510515-19-00