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

April 28, 2025 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
        • Recruiting
        • 058 - Aon Ss. Antonio E Biagio E C. Arrigo - Soc Ematologia
        • Contact:
      • Ancona, Italy
        • Recruiting
        • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi - Sod Clinica Ematologica
        • Contact:
      • Ascoli Piceno, Italy
        • Recruiting
        • Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
        • Contact:
      • Bari, Italy
        • Recruiting
        • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
        • Contact:
      • Bologna, Italy
        • Recruiting
        • Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
        • Contact:
      • Brescia, Italy
        • Recruiting
        • Asst Degli Spedali Civili Di Brescia - Uo Ematologia
        • Contact:
      • Brindisi, Italy
        • Recruiting
        • Asl Brindisi, Ospedale 'Perrino'- Uo Ematologia
        • Contact:
      • Castelfranco Veneto, Italy
        • Recruiting
        • U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs - Presidio Ospedaliero S. Giacomo Apostolo
        • Contact:
      • Catania, Italy
        • Recruiting
        • Aou Policlinico Vittorio Emanuele, Po Ospedaliero "G. Rodolico" - Uo Ematologia Con Trapianto Di Midollo Osseo
        • Contact:
      • Cona, Italy
        • Recruiting
        • Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
        • Contact:
      • Cuneo, Italy
      • Foggia, Italy
      • Latina, Italy
        • Recruiting
        • Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
        • Contact:
      • Lecce, Italy
      • Mestre, Italy
      • Milano, Italy
        • Recruiting
        • Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
        • Contact:
      • Milano, Italy
        • Recruiting
        • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
        • Contact:
      • Modena, Italy
        • Recruiting
        • Aou Di Modena - Sc Ematologia
        • Contact:
      • Napoli, Italy
        • Recruiting
        • Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
        • Contact:
      • Orbassano, Italy
        • Recruiting
        • Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
        • Contact:
      • Pagani, Italy
        • Recruiting
        • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
        • Contact:
      • Palermo, Italy
        • Recruiting
        • Aou Policlinico P. Giaccone - Uo Ematologia
        • Contact:
      • Pescara, Italy
        • Recruiting
        • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
        • Contact:
      • Piacenza, Italy
        • Recruiting
        • Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
        • Contact:
      • Pisa, Italy
      • Reggio Calabria, Italy
        • Recruiting
        • Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
        • Contact:
      • Reggio Emilia, Italy
      • Rimini, Italy
      • Roma, Italy
        • Recruiting
        • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
        • Contact:
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
        • Contact:
      • Roma, Italy
        • Recruiting
        • Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia
        • Contact:
      • Roma, Italy
      • Roma, Italy
        • Recruiting
        • Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
        • Contact:
      • Roma, Italy
      • Roma, Italy
      • Salerno, Italy
        • Recruiting
        • Aou "San Giovanni Di Sio E Ruggi D'Aragona" - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
        • Contact:
      • Sassari, Italy
        • Recruiting
        • Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
        • Contact:
      • Siena, Italy
        • Recruiting
        • Aou Senese - Uoc Ematologia E Trapianti
        • Contact:
      • Torino, Italy
        • Recruiting
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
        • Contact:
      • Torino, Italy
        • Recruiting
        • Aou Citta' Della Salute E Della Scienza - Osp. S. Giovanni Battista Molinette - Sc Ematologia 2
        • Contact:
      • Tricase, Italy
      • Udine, Italy
        • Recruiting
        • Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
        • Contact:
      • Verona, Italy
        • Recruiting
        • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
        • Contact:
      • Viterbo, Italy
        • Recruiting
        • Asl Di Viterbo, Complesso Ospedaliero Di Belcolle - Uoc Ematologia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, and IPSS-R intermediate to very-high
  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:

  1. Acute myeloid leukaemia with >20% blasts in BM or peripheral blood (PB);
  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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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)
Other Names:
  • STD CHT
Procedure: Allogeneic stem cell transplantation
Allogeneic stem cell transplantation
Other Names:
  • HSCT
Experimental: 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
Procedure: Allogeneic stem cell transplantation
Allogeneic stem cell transplantation
Other Names:
  • HSCT
Drug: Azacitidine
75mg/mq/day subcutaneously for 7 days every 28 days
Other Names:
  • AZA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Voso, Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2020

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 29, 2019

First Submitted That Met QC Criteria

November 29, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDS0519

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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