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

Fujian Medical University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

MDS-EB

Treatments

Drug: Azacitidine

Drug: CAG Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT04216355

MDS-SCT-01

Details and patient eligibility

About

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) .

Enrollment

20 estimated patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

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