Clincosm LogoSign in Get a demo

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

Sponsor
Fujian Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04216355
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
47
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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) .

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mean Time to Engraftment [Baseline to engraftment, assessed minimally 28 days post transplant]

Secondary Outcome Measures

  1. Cumulative Incidence of Graft-versus Host Disease [Up to 2 years]

  2. Incidence of systemic infections [Up to 2 years]

  3. Overall survival [Up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujian Medical University Union Hospital Fuzhou Fujian China 350001

Sponsors and Collaborators

  • Fujian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ting YANG, Principal Investigator, Fujian Medical University
ClinicalTrials.gov Identifier:
NCT04216355
Other Study ID Numbers:
  • MDS-SCT-01
First Posted:
Jan 2, 2020
Last Update Posted:
Jan 3, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Azacitidine

Study Results

No Results Posted as of Jan 3, 2020