Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome

April 27, 2015 updated by: Xiaojun Huang, Peking University People's Hospital

Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast >5%). However, many patients cannot find an HLA-matched donor. haploidentical donor is an alternative stem cell source.

the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can improve the survival of patients with myelodysplastic syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

116

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, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100781
        • Aerospace Center Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital, Nanfang Medical University
    • Hebei
      • Tangshan, Hebei, China
        • Hebei Tangshan Steel and Iron Company Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Gulou Hospital
      • Suzhou, Jiangsu, China
        • Suzhou University The 1st Affiliated Hospital
    • Sichuan
      • Chongqing, Sichuan, China
        • Chongqing Medical University The 1st Affiliated Hospital
      • Chongqing, Sichuan, China
        • The 3rd Army Medical University The 2nd Affiliated 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

2 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with MDS:1)intermediate-2 or high risk 2)low or intermediate-1 risk, drug resistance or disease progression

Description

Inclusion Criteria:

  • Patients with MDS (1)intermediate-2 or high risk (2)low or intermediate-1 risk with drug resistance or disease progression
  • without identical sibling donor

Exclusion Criteria:

  • Contraindication to HSCT
  • Pregnancy
  • Mental illness

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
haploidentical transplant
transplant with haploidentical donor
Procedure: transplant with haploidentical donor
patients with advanced MDS without identical sibling donor receive haploidentical transplant
Other Names:
  • haploidentical transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival rate
Time Frame: participants will be followed for an expected average of one year
number of participants with survival at one year
participants will be followed for an expected average of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of non-relapse mortality
Time Frame: one year
number of participants with non-relapse mortality at one year
one year

Collaborators and Investigators

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

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: xiaojun huang, M.D., Peking University People's Hospital

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

April 1, 2003

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUPH IRB [2013] (04)

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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