Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azacitidine, Standard Chemotherapy, Allogeneic stem cell transplantation.
- Who it may be relevant to
- Registry conditions: High-risk MDS. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug Azacitidine
75mg/mq/day subcutaneously for 7 days every 28 days - 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) - Procedure Allogeneic stem cell transplantation
Allogeneic stem cell transplantation
Primary outcome measures
- Feasibility of HSCT in terms of proportion of patients who receive HSCT of the total number of randomized patients [Time frame: 4 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 46 centers
- 058 - Aon Ss. Antonio E Biagio E C. Arrigo - Soc Ematologia — Alessandria
- Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi - Sod Clinica Ematologica — Ancona
- Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia — Ascoli Piceno
- Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto — Bari
- Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia — Bologna
- Asst Degli Spedali Civili Di Brescia - Uo Ematologia — Brescia
- Asl Brindisi, Ospedale 'Perrino'- Uo Ematologia — Brindisi
- U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs - Presidio Ospedaliero S. Giacomo — Castelfranco Veneto
- … and 38 more centers
Identifiers
NCT: NCT04184505 · MDS0519