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ACTIVE NOT RECRUITING
NCT00959140
NA

Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Related Donors

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

Stem cells collected from sibling donors for allogenic transplants contain various types of cells. The predominant immune cells are called CD3+ T cells. The amount of these T cells vary vastly from donor to donor. This study is to determine if standardizing the CD3+ T cell dose will benefit the recipient (patient). As well as to help discover if dose standardization causes less variation in outcomes between patients and to make transplantation more predictable and complications easier to manage.

Official title: Phase II Study for Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplants From Matched Related Donors

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2014-10

Completion Date

2026-12-31

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

DEVICE

CD3+ T cell depletion

The peripheral blood stem cell product is engineered to deliver a dose of 15 to 20 x10\^7 CD3+ cells/kg recipient body weight. Other components of the graft will not be manipulated and the recipient will receive the total number of cells collected with the exception of minimal losses that occur during the process of CD3+ T cell isolation. Following collection, CD3+ T cells will be enumerated and a portion of the product containing 15 to 20 x10\^7 CD 3+ cells/kg will be set aside. The remainder of the product will be depleted of CD3+ T cells. Following CD3+ T cell depletion, the CD3+ T cell depleted product will then be combined with the unmanipulated product to provide the specified levels of CD3+ T cells/kg recipient body-weight. The graft is infused into the patient on the same day as selected and within 24 hours of donor aphaeresis.

Locations (1)

University of Alabama Hospital

Birmingham, Alabama, United States