Haplo-identical/Mismatched Hematopoietic Stem Cell Transp... | NCT01793675

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

NCT01793675

Sponsor

Peking University People's Hospital

Status

Completed

Last Update Posted

Apr 29, 2015Estimated

Enrollment

116Actual

Phase

Not provided

Conditions

Advanced MDS Without Identical Sibling Donor

Interventions

transplant with haploidentical donor

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2014Actual

First Submitted Date

Feb 14, 2013

First Submission Date that Met QC Criteria

Feb 14, 2013

First Posted Date

Feb 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2015

Last Update Posted Date

Apr 29, 2015Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
haploidentical transplant		transplant with haploidentical donor	Procedure: transplant with haploidentical donor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transplant with haploidentical donor	Procedure	patients with advanced MDS without identical sibling donor receive haploidentical transplant	haploidentical transplant

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
xiaojun huang, M.D.	Peking University People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanfang Hospital, Nanfang Medical University		Guangzhou	Guangdong	510515	China
Hebei Tangshan Steel and Iron Company Hospital

Intervention Browse Module

MeSH Terms

ID	Term
D014180	Transplantation

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

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Browse Branches

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