Cell Selection for Bone Marrow Transplants to Prevent Gra... | NCT00001872

Studies
Cell Selection for Bone Marrow Transplants to Prevent Graft-Versus-Host-Disease

NCT00001872

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Status

Completed

Last Update Posted

Dec 17, 2019Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Graft vs Host Disease
Hematologic Neoplasm

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

ID	Type	Description	Link
99-H-0037

Status Module

Record Verification Date

Mar 2, 2018

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

Feb 2, 1999

Primary Completion Date

Not provided

Completion Date

Mar 2, 2018

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Nov 3, 1999

First Posted Date

Nov 4, 1999Estimated

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 14, 2019

Last Update Posted Date

Dec 17, 2019Actual

Description Module

Brief Summary

Blood contains different kinds of cells, white blood cells, red blood cells, and platelets. In order to treat certain diseases, specific cell types can be removed from blood and transplanted into patients. The process of removing white blood cells for the treatment of leukemia is called apheresis.

This study will make available blood cell collections from volunteers genetically matched to various degrees with recipients in order to test and, if necessary, refine the process of removing white blood cell T-lymphocytes....

Detailed Description

This protocol has been written to make available apheresis collections from volunteers matched to various degrees with recipients in order to test and, if necessary refine, the selective immunodepletion procedure prior to introducing it in a clinical trial.

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

14Actual

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Family members of patients admitted to NHLBI allogeneic BMT protocols.

Ages 18 and older and less than age 65.

Parent of patient (obligate haplotype match) OR HLA 3/6, 4/6, 5/6, or 6/6 match with patient.

Research apheresis available from patient.

EXCLUSION CRITERIA:

Pregnancy or lactation.

HLA type unknown.

More than one haplotype mismatch with patient.

History of any immunosuppressive disease.

History of chronic viral antigenic stimulus.

Venous access inadequate.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
A. John Barrett, M.D.	National Heart, Lung, and Blood Institute (NHLBI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7858526	Background	Datta AR, Barrett AJ, Jiang YZ, Guimaraes A, Mavroudis DA, van Rhee F, Gordon AA, Madrigal A. Distinct T cell populations distinguish chronic myeloid leukaemia cells from lymphocytes in the same individual: a model for separating GVHD from GVL reactions. Bone Marrow Transplant. 1994 Oct;14(4):517-24.
8733700	Background

ID	Term
D006086	Graft vs Host Disease
D019337	Hematologic Neoplasms

ID	Term
D007154	Immune System Diseases
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases