Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)
NCT ID: NCT04184505
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
274 participants
INTERVENTIONAL
2020-11-27
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard clinical treatment
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
Standard Chemotherapy
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
Allogeneic stem cell transplantation
Experimental treatment
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
Azacitidine
75mg/mq/day subcutaneously for 7 days every 28 days
Allogeneic stem cell transplantation
Allogeneic stem cell transplantation
Interventions
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Azacitidine
75mg/mq/day subcutaneously for 7 days every 28 days
Standard Chemotherapy
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
Allogeneic stem cell transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18-70 years
3. Previously untreated for HR-MDS
4. HSCT - eligible
5. Life expectancy ≥3 months;
6. Signed written informed consent according to ICH/EU/GCP and national local laws
7. Eastern Cooperative Oncology Group Performance Status Grade of 0-2
Exclusion Criteria
2. concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);
3. severe renal, cardiac, liver or lung impairment;
4. 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.
5. HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis;
6. clinically relevant neurological or psychiatric diseases;
7. hypersensitivity (known or suspected) to AZA;
8. prior Treatments:
1. prior investigational drugs (within 30 days);
2. radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months;
3. growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days;
4. androgenic hormones during the previous 14 days;
5. 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).
18 Years
70 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Voso
Role: PRINCIPAL_INVESTIGATOR
AOU POLICLINICO TOR VERGATA - ROMA - UOC TRAPIANTO CELLULE STAMINALI
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MDS0519
Identifier Type: -
Identifier Source: org_study_id
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