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Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT

Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT

Recruiting
65 years and younger
All
Phase 2/3

Overview

This single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) .

Eligibility

Inclusion Criteria:

  • New Diagnosed advanced myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant is planned
  • Recipient of an allogeneic hematopoietic stem cell transplantation
  • Age < 65 years
  • ECOG performance status 2
  • Written informed consent
  • No psychological, familial, social, or geographic reason that would compromise clinical follow up

Exclusion Criteria:

  • Relapsed or refractory advanced MDS
  • Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment
  • Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials
  • Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
  • A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications

Study details
    MDS-EB

NCT04216355

Fujian Medical University

16 February 2024

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