Chronic GVHD Prevention Through Naïve T Cell Depletion in BMT Transplants for Leukemia – Phase II

Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-versus-host Disease in Children and Young Adults with Blood Cancers Undergoing Donor Stem Cell Transplant

Protocol Description

This multi-center research program evaluates the effectiveness of blood and marrow transplants that have been depleted of a type of immune lymphocyte called a naïve T cell when given to patients with leukemia or related blood disorder. In patients who receive blood transplants, naïve T cells can increase the risk of a dangerous condition called graft-versus-host disease (GVHD), in which T cells from the donor (the graft) attack the transplant recipient’s cells (the host). Researchers believe that patients receiving peripheral blood stem cells or bone marrow that has been depleted of the naïve T cells will experience less or no chronic GVHD without increasing the risk of infection.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients who have leukemia or a related blood disorder that will be treated with a stem cell transplant using either peripheral blood stem cells or bone marrow from a matched related or unrelated donor.
Males and Females: 6 months to 22 years of age


In the days leading up to transplant, participants will receive a conditioning regimen consisting of radiation and chemotherapy in the hospital setting. Following transplant of the naïve T cell depleted stem cell product, participants will receive immunosuppressants over 50 days, with weekly monitoring and periodic research tests done for up to a year. Additional follow up visits will be scheduled for 15, 18, 21 and 24 months following transplant.
Visits: Similar to standard of care for bone marrow transplant
Duration: About 2 years

Status: Open to Enrollment

Source(s) of Support

Center for International Blood & Marrow Transplant Research
Fred Hutchinson Cancer Research Center
Miltenyi Biotec Inc.
National Marrow Donor Program
Pediatric Blood and Marrow Transplantation Consortium
St. Baldrick’s Foundation

Primary Investigator

Craig Byersdorfer, MD

Contact Information

For more information about the study or enrollment, please contact:
Shawna McIntyre, Clinical Research Supervisor