Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

July 12, 2016 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Affiliated Hospital of Academy of Military Medical Sciences

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

10 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
  • International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
  • bone marrow blasts > 11% or <= 10% and poor cytogenetics;
  • lack of an HLA-identical donor;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • adequate cardiac and hepatorenal functions.

Exclusion Criteria:

  • have an HLA-identical donor

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decitabine and cytarabine
induction therapy：decitabine 25mg/m2 daily for 4 days with cytarabine 150 mg/m2 daily for 7 days consolidation：decitabine 25mg/m2 daily for 4 days with cytarabine 2g/m2 q12h for 3 days
Biological: Microtransplantation
Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete remission
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: three years
three years

Other Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: three years
three years

Collaborators and Investigators

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

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Collaborators

The Second Artillery General Hospital

Investigators

  • Principal Investigator: Sheng Hui Ai, M.D, Affiliated Hospital of Academy of Military Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 25, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MST/MDS-307PLAH-ASH

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.

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