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

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Hematopoietic Stem Cell Transplantation
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."

Trial Locations (1)

35294

University of Alabama Hospital, Birmingham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Miltenyi Biotec, Inc.

INDUSTRY

lead

University of Alabama at Birmingham

OTHER