Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)
ACROBAT
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
1 other identifier
interventional
274
1 country
46
Brief Summary
Open-label, randomized multicenter phase III non-inferiority study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2020
Longer than P75 for phase_3
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedStudy Start
First participant enrolled
November 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedApril 29, 2025
April 1, 2025
5.3 years
November 29, 2019
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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%.
4 years
Study Arms (2)
Standard clinical treatment
ACTIVE COMPARATORIf 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
EXPERIMENTALIf 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
Interventions
75mg/mq/day subcutaneously for 7 days every 28 days
1. 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)
Allogeneic stem cell transplantation
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
058 - Aon Ss. Antonio E Biagio E C. Arrigo - Soc Ematologia
Alessandria, Italy
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi - Sod Clinica Ematologica
Ancona, Italy
Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno, Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia, Italy
Asl Brindisi, Ospedale 'Perrino'- Uo Ematologia
Brindisi, Italy
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs - Presidio Ospedaliero S. Giacomo Apostolo
Castelfranco Veneto, Italy
Aou Policlinico Vittorio Emanuele, Po Ospedaliero "G. Rodolico" - Uo Ematologia Con Trapianto Di Midollo Osseo
Catania, Italy
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona, Italy
Aso S. Croce E Carle - Sc Ematologia
Cuneo, Italy
Aou Ospedali Riuniti- Uoc Ematologia
Foggia, Italy
Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
Latina, Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce, Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo Uo Ematologia
Mestre, Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan, Italy
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
Milan, Italy
Aou Di Modena - Sc Ematologia
Modena, Italy
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
Napoli, Italy
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
Orbassano, Italy
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Pagani, Italy
Aou Policlinico P. Giaccone - Uo Ematologia
Palermo, Italy
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara, Italy
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza, Italy
Aou Pisana - Uo Ematologia Universitaria
Pisa, Italy
Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
Reggio Calabria, Italy
Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia, Italy
Ausl Della Romagna, Ospedale "Infermi" - Uo Ematologia
Rimini, Italy
Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia
Roma, Italy
Ao San Camillo Forlanini Uoc Ematologia E Trapianto Cellule Staminali
Roma, Italy
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
Roma, Italy
Aou Sant'Andrea - Roma - Uoc Ematologia
Roma, Italy
Asl Roma 2, Ospedale S. Eugenio- Uoc Ematologia
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, Italy
Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia
Roma, Italy
Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
Roma, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma, Italy
Aou "San Giovanni Di Sio E Ruggi D'Aragona" - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
Salerno, Italy
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
Sassari, Italy
Aou Senese - Uoc Ematologia E Trapianti
Siena, Italy
Aou Citta' Della Salute E Della Scienza - Osp. S. Giovanni Battista Molinette - Sc Ematologia 2
Torino, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino, Italy
ENTE ECCLESIASTICO CARDINALE G. PANICo - UO EMATOLOGIA
Tricase, Italy
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine, Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona, Italy
Asl Di Viterbo, Complesso Ospedaliero Di Belcolle - Uoc Ematologia
Viterbo, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Voso
AOU POLICLINICO TOR VERGATA - ROMA - UOC TRAPIANTO CELLULE STAMINALI
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2019
First Posted
December 3, 2019
Study Start
November 27, 2020
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
April 29, 2025
Record last verified: 2025-04