Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (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
Gruppo Italiano Malattie EMatologiche dell'Adulto
274 participants
Nov 27, 2020
INTERVENTIONAL
Conditions
Summary
Open-label, randomized multicenter phase III non-inferiority study
Eligibility
Inclusion Criteria7
- 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 Criteria13
- 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).
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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
Locations(46)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04184505