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

NCT04184505 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-04-29

No results posted yet for this study

Summary

Open-label, randomized multicenter phase III non-inferiority study

Conditions

  • High-risk MDS

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

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Principal Investigators

  • Voso · AOU POLICLINICO TOR VERGATA - ROMA - UOC TRAPIANTO CELLULE STAMINALI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-27
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04184505 on ClinicalTrials.gov