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

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Fujian Medical University
Updated on 16 February 2024
stem cell transplantation
cell transplantation
azacitidine
myelodysplastic syndromes
allogeneic hematopoietic stem cell transplant
raeb
myelodysplastic syndrome
cag protocol

Summary

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) .

Details
Condition MDS-EB
Age 65years or below
Treatment Azacitidine, CAG Protocol
Clinical Study IdentifierNCT04216355
SponsorFujian Medical University
Last Modified on16 February 2024

Eligibility

Yes No Not Sure

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
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