Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)

Recruiting now · Phase 3

Conditions studied: High-risk MDS

In brief

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

Key facts

Study ID

NCT04184505

Run by

Gruppo Italiano Malattie EMatologiche dell'Adulto

People needed

274

Starts

2020-11-27

Expected to finish

2026-03-01

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Acute myeloid leukaemia with >20% blasts in BM or peripheral blood (PB);
• concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);
• severe renal, cardiac, liver or lung impairment;
• 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.
• HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis;
• clinically relevant neurological or psychiatric diseases;
• hypersensitivity (known or suspected) to AZA;
• 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).

Where it is running

• 058 - Aon Ss. Antonio E Biagio E C. Arrigo - Soc Ematologia — Alessandria, Italy (enrolling)
• Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi - Sod Clinica Ematologica — Ancona, Italy (enrolling)
• Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia — Ascoli Piceno, Italy (enrolling)
• Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto — Bari, Italy (enrolling)
• Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia — Bologna, Italy (enrolling)
• Asst Degli Spedali Civili Di Brescia - Uo Ematologia — Brescia, Italy (enrolling)
• Asl Brindisi, Ospedale 'Perrino'- Uo Ematologia — Brindisi, Italy (enrolling)
• U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs - Presidio Ospedaliero S. Giacomo Apostolo — Castelfranco Veneto, Italy (enrolling)
• Aou Policlinico Vittorio Emanuele, Po Ospedaliero "G. Rodolico" - Uo Ematologia Con Trapianto Di Midollo Osseo — Catania, Italy (enrolling)
• Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione — Cona, Italy (enrolling)
• Aso S. Croce E Carle - Sc Ematologia — Cuneo, Italy (enrolling)
• Aou Ospedali Riuniti- Uoc Ematologia — Foggia, Italy (enrolling)
• Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia — Latina, Italy (enrolling)
• Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia — Lecce, Italy (enrolling)
• Aulss 3 Serenissima, Ospedale Dell'Angelo Uo Ematologia — Mestre, Italy (enrolling)
• Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia — Milan, Italy (enrolling)
• Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia — Milan, Italy (enrolling)
• Aou Di Modena - Sc Ematologia — Modena, Italy (enrolling)
• Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo — Naples, Italy (enrolling)
• Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia — Orbassano, Italy (enrolling)
• Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia — Pagani, Italy (enrolling)
• Aou Policlinico P. Giaccone - Uo Ematologia — Palermo, Italy (enrolling)
• Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica — Pescara, Italy (enrolling)
• Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti — Piacenza, Italy (enrolling)
• Aou Pisana - Uo Ematologia Universitaria — Pisa, Italy (enrolling)

Full record on ClinicalTrials.gov

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