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
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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) .

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University
• Treatments: Azacitidine

Criteria

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