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

NCT04216355 | Unknown Phase 2

• 1 other identifier: MDS-SCT-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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) .

Conditions

MDS-EB

Outcome Measures

Primary Outcomes (1)

• Mean Time to Engraftment

  Baseline to engraftment, assessed minimally 28 days post transplant

Secondary Outcomes (3)

• 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

Study Arms (1)

AZA with CAG derived regimen

EXPERIMENTAL

Azacitidine 50mg/m²/day, D1-D5 (IV) Aclarubicin 5mg/m²/day, D1-D4 (IV) Cytarabine 10mg/m²/12h, D1-D6 (IV) G-CSF 5-10ug/kg/day, D1-D7 (SC)

Drug: Azacitidine; Drug: CAG Protocol

Interventions

Azacitidine DRUG

Low-dose AZA

AZA with CAG derived regimen

CAG Protocol DRUG

Short term CAG derived regimen

AZA with CAG derived regimen

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Interventions

Azacitidine; CAG protocol

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Ting Yang, Prof.M.D.Ph.D

CONTACT

86-591-86218441; yang.hopeting@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: January 3, 2020

Record last verified: 2020-01

Locations

CN (1)