High-risk MDSPhase 3ACROBATNCT04184505
Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)
A Phase 3 study testing Azacitidine, Standard Chemotherapy and Allogeneic stem cell transplantation in people with High-risk MDS, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 46 sites in Italy.
Trial summary
Open-label, randomized multicenter phase III non-inferiority study Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- High-risk MDS
- What is being tested?
- Azacitidine, Standard Chemotherapy and Allogeneic stem cell transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 46 sitesItaly
- Study dates
- 27 Nov 2020to 1 Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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).
Trial locations and contacts
46 sites in 1 country. Contact the study team or a site near you to ask about taking part.
46 sites in 1 country
Italy46 sites, 46 recruiting
- Recruiting
058 - Aon Ss. Antonio E Biagio E C. Arrigo - Soc Ematologia
Alessandria
Zallio, 00, fazallio@ospedale.al.it
- Recruiting
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi - Sod Clinica Ematologica
Ancona
Poloni, 0715964736, a.poloni@univpm.it
- Recruiting
Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno
Galieni, 0736358128, piero.galieni@sanita.marche.it
- Recruiting
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari
Paola Carluccio, 3383401921, paola.carluccio@policlinico.ba.it
- Recruiting
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna
Carlo Finelli, 3355444425, carlo.finelli@unibo.it
- Recruiting
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia
Erika Borlenghi, 3402526539, erika.borlenghi@gmail.com
- Recruiting
Asl Brindisi, Ospedale 'Perrino'- Uo Ematologia
Brindisi
Pastore, 3393061521, domenico.pastore0@gmail.com
- Recruiting
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs - Presidio Ospedaliero S. Giacomo Apostolo
Castelfranco Veneto
Gottardi, 3476260749, michele.gottardi@aulss2.veneto.it
- Recruiting
Aou Policlinico Vittorio Emanuele, Po Ospedaliero "G. Rodolico" - Uo Ematologia Con Trapianto Di Midollo Osseo
Catania
Milone, 00, giuseppe.milone@gmail.com
- Recruiting
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona
Cuneo, 0532236977, cut@unife.it
- Recruiting
Aso S. Croce E Carle - Sc Ematologia
Cuneo
Mordini, 00, mordini.n@ospedale.cuneo.it
- Recruiting
Aou Ospedali Riuniti- Uoc Ematologia
Foggia
Melillo, 0881736444, lmelillo@ospedaliriunitifoggia.it
- Recruiting
Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
Latina
Giuseppe Cimino, 3495378159, cimino@bce.uniroma1.it
- Recruiting
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce
Di Renzo, 0832661922, direnzo.ematolecce@gmail.com
- Recruiting
Aulss 3 Serenissima, Ospedale Dell'Angelo Uo Ematologia
Mestre
Sancetta, 00, rosaria.sancetta@aulss3.veneto.it
- Recruiting
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan
Roberto S Cairoli, 3478939057, roberto.cairoli@ospedaleniguarda.it
- Recruiting
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
Milan
Fabio Ciceri, 0226437503, ciceri.clinicaltrials@hsr.it
- Recruiting
Aou Di Modena - Sc Ematologia
Modena
Mario Luppi, 0594224641, mario.luppi@unimore.it
- Recruiting
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
Naples
Alessandra Picardi, 081 7472260, alessandra.picardi@aocardarelli.it
- Recruiting
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
Orbassano
Daniela Cilloni, 3332818086, daniela.cilloni@unito.it
- Recruiting
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Pagani
Califano, 0819213366, c.califano@aslsalerno.it
- Recruiting
Aou Policlinico P. Giaccone - Uo Ematologia
Palermo
Siragusa, 00, sergio.siragusa@unipa.it
- Recruiting
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara
Santarone, 00, stella.santarone@ausl.pe.it
- Recruiting
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza
Vallisa, 0523303701, d.vallisa@ausl.pc.it
- Recruiting
Aou Pisana - Uo Ematologia Universitaria
Pisa
Petrini, 050 993488, mario.petrini@med.unipi.it
- Recruiting
Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
Reggio Calabria
Ester Olivia, 3297978204, enoliva@gmail.com
- Recruiting
Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia
Capodanno, 00, isabella.capodanno@ausl.re.it
- Recruiting
Ausl Della Romagna, Ospedale "Infermi" - Uo Ematologia
Rimini
Tomassetti, 00, simona.tomassetti@auslromagna.it
- Recruiting
Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia
Roma
Laura Cudillo, 3398320774, lcudillo@hsangiovanni.roma.it
- Recruiting
Ao San Camillo Forlanini Uoc Ematologia E Trapianto Cellule Staminali
Roma
Santopietro, 0658703485, msantopietro@scamilloforlanini.rm.it
- Recruiting
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
Roma
Maria Teresa Voso, 3494743547, Voso@Med.uniroma2.it
- Recruiting
Aou Sant'Andrea - Roma - Uoc Ematologia
Roma
Agostino Tafuri, 3392145880, agostino.tafuri@ospedalesantandrea.it
- Recruiting
Asl Roma 2, Ospedale S. Eugenio- Uoc Ematologia
Roma
De Fabritiis, 0651005740, paolo.defabritiis@aslroma2.it
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma
Luana Fianchi, 3479378107, luana.fianchi@policlinicogemelli.it
- Recruiting
Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia
Roma
Gumenyuk Svitlana, 00, svitlana.gumenyuk@ifo.gov.it
- Recruiting
Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
Roma
Giuseppe Avvisati, 3281595114, g.avvisati@unicampus.it
- Recruiting
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma
Breccia, 06 49974440, breccia@bce.uniroma1.it
- Recruiting
Aou "San Giovanni Di Sio E Ruggi D'Aragona" - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
Salerno
Selleri, 089 673152, cselleri@unisa.it
- Recruiting
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
Sassari
Claudio Fozza, 3397560639, cfozza@uniss.it
- Recruiting
Aou Senese - Uoc Ematologia E Trapianti
Siena
Bocchia, 0577586740, bocchia@unisi.it
- Recruiting
Aou Citta' Della Salute E Della Scienza - Osp. S. Giovanni Battista Molinette - Sc Ematologia 2
Torino
Frairia, 00, chiara.frairia@med.uniupo.it
- Recruiting
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino
Benedetto Bruno, 00, benedetto.bruno@unito.it
- Recruiting
ENTE ECCLESIASTICO CARDINALE G. PANICo - UO EMATOLOGIA
Tricase
Pavone, 0833773450, salentoematologia@piafondazionepanico.it
- Recruiting
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine
Tiribelli, 0432559701, mario.tiribelli@uniud.it
- Recruiting
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona
Tanasi, 00, ilaria_tanasi@hotmail.com
- Recruiting
Asl Di Viterbo, Complesso Ospedaliero Di Belcolle - Uoc Ematologia
Viterbo
Di Veroli, 00, ambra.diveroli@asl.vt.it
About this study
Official title: 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
Read the detailed description
Open-label, randomized, prospective multicenter phase III study to compare the role of HMT followed by HSCT vs HSCT upfront in HR-MDS with <10% of BM blasts and of CHT vs HMT followed by HSCT in HR-MDS with >10% BM blasts in terms of feasibility of HSCT (non-inferiority trial).
- Conditions
- High-risk MDS
- Being tested
- Azacitidine, Standard Chemotherapy, Allogeneic stem cell transplantation
- Keywords
- MDS, Transplant, Azacitidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called AZA
75mg/mq/day subcutaneously for 7 days every 28 days
Standard ChemotherapyDrug
Also called STD CHT
- cycle (induction): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 60 mg/mq iv day 1-3)
- cycle (consolidation): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 45 mg/mq iv day 1-3)
Allogeneic stem cell transplantationProcedure or surgery
Also called HSCT
Allogeneic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Standard clinical treatment | Active comparator | If BM-blasts >= 10%: Conventional chemotherapy: induction one cycle (3+7 protocol) and one optional consolidation cycle, followed by HSCT if a suitable sibling or unrelated donor is available versus
If BM blasts are <10%: HSCT upfront Receives: Drug: Standard Chemotherapy; Procedure: Allogeneic stem cell transplantation |
| Experimental treatment | Experimental | If BM-blasts >= 10%: Azacitidine (AZA) 75mg/sqm/day subcutaneously for 7 days every 28 days (1 cycle of 28 days) for at least 4 cycles, followed by HSCT if a suitable sibling or unrelated donor is available
If BM blasts are <10%: Azacitidine (AZA) 75mg/sqm/day subcutaneously for 7 days every 28 days (1 cycle of 28 days) for at least 4 cycles, followed by HSCT if a suitable sibling or unrelated donor is available Receives: Drug: Azacitidine; Procedure: Allogeneic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of HSCT in terms of proportion of patients who receive HSCT of the total number of randomized patients
Split patients in two categories: the feasibility of HSCT (ITT) in patients with HR-MDS with a proportion of bone marrow blasts below 10% and in patients with a proportion of BM blasts equal or greater than 10%.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start27 Nov 2020
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk MDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Voso, Principal investigator, AOU POLICLINICO TOR VERGATA - ROMA - UOC TRAPIANTO CELLULE STAMINALI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184505
- Sponsor's protocol ID
- MDS0519
- Acronym
- ACROBAT
- Status last verified
- Apr 2025
- First submitted
- 29 Nov 2019
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04184505
- Acronym / sponsor ID
- ACROBAT / MDS0519
- Conditions
- High-risk MDS
- Keywords
- MDS, Transplant, Azacitidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, randomized multicenter phase III non-inferiority study
Detailed description
Open-label, randomized, prospective multicenter phase III study to compare the role of HMT followed by HSCT vs HSCT upfront in HR-MDS with <10% of BM blasts and of CHT vs HMT followed by HSCT in HR-MDS with >10% BM blasts in terms of feasibility of HSCT (non-inferiority trial).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard clinical treatment | Active comparator | Drug: Standard Chemotherapy, Procedure: Allogeneic stem cell transplantationIf BM-blasts >= 10%: Conventional chemotherapy: induction one cycle (3+7 protocol) and one optional consolidation cycle, followed by HSCT if a suitable sibling or unrelated donor is available versus If BM blasts are <10%: HSCT upfront |
| Experimental treatment | Experimental | Drug: Azacitidine, Procedure: Allogeneic stem cell transplantationIf BM-blasts >= 10%: Azacitidine (AZA) 75mg/sqm/day subcutaneously for 7 days every 28 days (1 cycle of 28 days) for at least 4 cycles, followed by HSCT if a suitable sibling or unrelated donor is available If BM blasts are <10%: Azacitidine (AZA) 75mg/sqm/day subcutaneously for 7 days every 28 days (1 cycle of 28 days) for at least 4 cycles, followed by HSCT if a suitable sibling or unrelated donor is available |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAlso: AZA75mg/mq/day subcutaneously for 7 days every 28 days | Drug | Experimental treatment |
| Standard ChemotherapyAlso: STD CHT1. cycle (induction): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 60 mg/mq iv day 1-3) 2. cycle (consolidation): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 45 mg/mq iv day 1-3) | Drug | Standard clinical treatment |
| Allogeneic stem cell transplantationAlso: HSCTAllogeneic stem cell transplantation | Procedure or surgery | Experimental treatment, Standard clinical treatment |
Primary outcome
Feasibility of HSCT in terms of proportion of patients who receive HSCT of the total number of randomized patients
Time frame: 4 years
Split patients in two categories: the feasibility of HSCT (ITT) in patients with HR-MDS with a proportion of bone marrow blasts below 10% and in patients with a proportion of BM blasts equal or greater than 10%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
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Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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R/R AML, R/R HR-MDS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Voso principal investigator
AOU POLICLINICO TOR VERGATA - ROMA - UOC TRAPIANTO CELLULE STAMINALI
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azacitidine, Standard Chemotherapy and Allogeneic stem cell transplantation in people with High-risk MDS, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 46 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of HSCT in terms of proportion of patients who receive HSCT of the total number of randomized patients (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.