Actively Recruiting
Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)
Led by Gruppo Italiano Malattie EMatologiche dell'Adulto · Updated on 2025-04-29
274
Participants Needed
46
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Open-label, randomized multicenter phase III non-inferiority study
CONDITIONS
Official Title
Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Eligible for hematopoietic stem cell transplantation
- Life expectancy of at least 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 will not qualify if you...
- Acute myeloid leukemia with more than 20% blasts in bone marrow or peripheral blood
- Concurrent malignancy diagnosed in the past 12 months (except skin basalioma)
- Severe renal, cardiac, liver, or lung impairment
- Pregnant, lactating, or potentially fertile without agreeing to avoid pregnancy during the trial; women of childbearing potential and men must use effective contraception during and up to 3 months after azacitidine treatment
- HIV infection; active, uncontrolled hepatitis C or B infections or liver cirrhosis
- Clinically relevant neurological or psychiatric diseases
- Known or suspected hypersensitivity to azacitidine
- Prior treatments including investigational drugs within 30 days
- Radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months
- Use of growth factors (EPO, G-CSF, or GM-CSF) within the previous 21 days
- Use of androgenic hormones within the previous 14 days
- Prior transplantation or cytotoxic therapy, including azacitidine or chemotherapy, for MDS (prior lenalidomide allowed if stopped at least 60 days before enrollment)
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
058 - Aon Ss. Antonio E Biagio E C. Arrigo - Soc Ematologia
Alessandria, Italy
Actively Recruiting
2
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi - Sod Clinica Ematologica
Ancona, Italy
Actively Recruiting
3
Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno, Italy
Actively Recruiting
4
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
Actively Recruiting
5
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, Italy
Actively Recruiting
6
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia, Italy
Actively Recruiting
7
Asl Brindisi, Ospedale 'Perrino'- Uo Ematologia
Brindisi, Italy
Actively Recruiting
8
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs - Presidio Ospedaliero S. Giacomo Apostolo
Castelfranco Veneto, Italy
Actively Recruiting
9
Aou Policlinico Vittorio Emanuele, Po Ospedaliero "G. Rodolico" - Uo Ematologia Con Trapianto Di Midollo Osseo
Catania, Italy
Actively Recruiting
10
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona, Italy
Actively Recruiting
11
Aso S. Croce E Carle - Sc Ematologia
Cuneo, Italy
Actively Recruiting
12
Aou Ospedali Riuniti- Uoc Ematologia
Foggia, Italy
Actively Recruiting
13
Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
Latina, Italy
Actively Recruiting
14
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce, Italy
Actively Recruiting
15
Aulss 3 Serenissima, Ospedale Dell'Angelo Uo Ematologia
Mestre, Italy
Actively Recruiting
16
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan, Italy
Actively Recruiting
17
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
Milan, Italy
Actively Recruiting
18
Aou Di Modena - Sc Ematologia
Modena, Italy
Actively Recruiting
19
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
Naples, Italy
Actively Recruiting
20
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
Orbassano, Italy
Actively Recruiting
21
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Pagani, Italy
Actively Recruiting
22
Aou Policlinico P. Giaccone - Uo Ematologia
Palermo, Italy
Actively Recruiting
23
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara, Italy
Actively Recruiting
24
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza, Italy
Actively Recruiting
25
Aou Pisana - Uo Ematologia Universitaria
Pisa, Italy
Actively Recruiting
26
Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
Reggio Calabria, Italy
Actively Recruiting
27
Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia, Italy
Actively Recruiting
28
Ausl Della Romagna, Ospedale "Infermi" - Uo Ematologia
Rimini, Italy
Actively Recruiting
29
Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia
Roma, Italy
Actively Recruiting
30
Ao San Camillo Forlanini Uoc Ematologia E Trapianto Cellule Staminali
Roma, Italy
Actively Recruiting
31
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
Roma, Italy
Actively Recruiting
32
Aou Sant'Andrea - Roma - Uoc Ematologia
Roma, Italy
Actively Recruiting
33
Asl Roma 2, Ospedale S. Eugenio- Uoc Ematologia
Roma, Italy
Actively Recruiting
34
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, Italy
Actively Recruiting
35
Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia
Roma, Italy
Actively Recruiting
36
Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
Roma, Italy
Actively Recruiting
37
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma, Italy
Actively Recruiting
38
Aou "San Giovanni Di Sio E Ruggi D'Aragona" - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
Salerno, Italy
Actively Recruiting
39
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
Sassari, Italy
Actively Recruiting
40
Aou Senese - Uoc Ematologia E Trapianti
Siena, Italy
Actively Recruiting
41
Aou Citta' Della Salute E Della Scienza - Osp. S. Giovanni Battista Molinette - Sc Ematologia 2
Torino, Italy
Actively Recruiting
42
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino, Italy
Actively Recruiting
43
ENTE ECCLESIASTICO CARDINALE G. PANICo - UO EMATOLOGIA
Tricase, Italy
Actively Recruiting
44
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine, Italy
Actively Recruiting
45
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona, Italy
Actively Recruiting
46
Asl Di Viterbo, Complesso Ospedaliero Di Belcolle - Uoc Ematologia
Viterbo, Italy
Actively Recruiting
Research Team
P
Paola Fazi
CONTACT
E
Enrico Crea
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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