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

MDS-EB Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04216355
• Other study ID #: MDS-SCT-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2020
• Est. completion date: December 2023

Study information

• Verified date: January 2020
• Source: Fujian Medical University
• Contact: Ting Yang, Prof.M.D.Ph.D
• Phone: 86-591-86218441
• Email: yang.hopeting[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

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

Related Conditions & MeSH terms

• MDS-EB

Intervention

Drug:
• Azacitidine
Low-dose AZA
• CAG Protocol
Short term CAG derived regimen

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Time to Engraftment		Baseline to engraftment, assessed minimally 28 days post transplant
Secondary	Cumulative Incidence of Graft-versus Host Disease		Up to 2 years
Secondary	Incidence of systemic infections		Up to 2 years
Secondary	Overall survival		Up to 2 years