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

January 1, 2020 updated by: Ting YANG, Fujian Medical University

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)

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) .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AZA with CAG derived regimen
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
Low-dose AZA
Drug: CAG Protocol
Short term CAG derived regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Time to Engraftment
Time Frame: Baseline to engraftment, assessed minimally 28 days post transplant
Baseline to engraftment, assessed minimally 28 days post transplant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

December 30, 2019

First Posted (ACTUAL)

January 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 1, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDS-SCT-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on MDS-EB

Clinical Trials on Azacitidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe