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

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)

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04216355

Enrollment

Registered

2020-01-02

Start date

2020-01-31

Completion date

2023-12-31

Last updated

2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MDS-EB

Brief 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) .

Interventions

DRUGAzacitidine

Low-dose AZA

DRUGCAG Protocol

Short term CAG derived regimen

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Mean Time to Engraftment	Baseline to engraftment, assessed minimally 28 days post transplant

Secondary

Measure	Time frame
Cumulative Incidence of Graft-versus Host Disease	Up to 2 years
Incidence of systemic infections	Up to 2 years
Overall survival	Up to 2 years

Countries

China

Contacts

Primary ContactTing Yang, Prof.M.D.Ph.D

yang.hopeting@gmail.com86-591-86218441

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026