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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793675
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang, Peking University People's Hospital

Brief Summary:

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


Condition or disease Intervention/treatment
Advanced MDS Without Identical Sibling Donor Procedure: transplant with haploidentical donor

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Study Type : Observational
Actual Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome
Study Start Date : April 2003
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: haploidentical transplant




Primary Outcome Measures :
  1. survival rate [ Time Frame: participants will be followed for an expected average of one year ]
    number of participants with survival at one year


Secondary Outcome Measures :
  1. incidence of non-relapse mortality [ Time Frame: one year ]
    number of participants with non-relapse mortality at one year



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793675


Locations
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China, Guangdong
Nanfang Hospital, Nanfang Medical University
Guangzhou, Guangdong, China, 510515
China, Hebei
Hebei Tangshan Steel and Iron Company Hospital
Tangshan, Hebei, China
China, Jiangsu
Nanjing Gulou Hospital
Nanjing, Jiangsu, China
Suzhou University The 1st Affiliated Hospital
Suzhou, Jiangsu, China
China, Sichuan
Chongqing Medical University The 1st Affiliated Hospital
Chongqing, Sichuan, China
The 3rd Army Medical University The 2nd Affiliated Hospital
Chongqing, Sichuan, China
China
Peking University People's Hospital
Beijing, China, 100044
Aerospace center hospital
Beijing, China, 100781
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: xiaojun huang, M.D. Peking University People's Hospital

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Responsible Party: Xiaojun Huang, Prof., Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01793675    
Other Study ID Numbers: PUPH IRB [2013] (04)
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms