NCT04184505

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• High-risk MDS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-27
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2019-12-03
• Last updated: 2025-04-29

Locations

46 sites across 1 country: Italy