Evaluation of Immunoregulatory Cells in Hematopoietic Ste... | NCT00179049

Studies
Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant

NCT00179049

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Dec 15, 2008Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Hematopoietic Stem Cell Transplantation
Graft vs Host Disease

Interventions

Not provided

Countries

United States

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

Dec 2008

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

Not provided

Completion Date

Apr 2008Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

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

Dec 12, 2008

Last Update Posted Date

Dec 15, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease.

Detailed Description

The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease (GVHD) by determining the qualitative and quantitative changes in T regulatory cells throughout the transplant process. Their understanding of this can lead to new treatment strategies and improved clinical therapeutic implications.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

100Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions

Exclusion Criteria:

Patients < 18 or > 70 years old undergoing either autologous transplant or allogeneic transplant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adetola A Kassim, M.D.	Vanderbilt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232-5505	United States