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

Completed

• Conditions: Advanced MDS Without Identical Sibling Donor
• Interventions: Procedure: transplant with haploidentical donor

• Registration Number: NCT01793675
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2012-12
• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
haploidentical transplant	transplant with haploidentical donor	transplant with haploidentical donor

Primary Outcome Measures

Name	Time	Method
survival rate	participants will be followed for an expected average of one year	number of participants with survival at one year

Secondary Outcome Measures

Name	Time	Method
incidence of non-relapse mortality	one year	number of participants with non-relapse mortality at one year

Trial Locations

Locations (8)

Nanfang Hospital, Nanfang Medical University; 🇨🇳 Guangzhou, Guangdong, China

Nanjing Gulou Hospital; 🇨🇳 Nanjing, Jiangsu, China

Suzhou University The 1st Affiliated Hospital; 🇨🇳 Suzhou, Jiangsu, China

Chongqing Medical University The 1st Affiliated Hospital; 🇨🇳 Chongqing, Sichuan, China

Hebei Tangshan Steel and Iron Company Hospital; 🇨🇳 Tangshan, Hebei, China

Aerospace center hospital; 🇨🇳 Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, China

The 3rd Army Medical University The 2nd Affiliated Hospital; 🇨🇳 Chongqing, Sichuan, China