Phase II Study of Removing Naive T Cells to Prevent Chronic Graft-Versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

What this Trial Is About

This trial evaluates naive T-cell depletion to prevent chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplants. It is a phase II randomized study comparing outcomes between patients receiving naive T-cell depleted peripheral blood stem cells and those receiving unmanipulated bone marrow. The study aims to reduce the harmful donor immune response that sometimes attacks the patients normal tissues after transplant. Participants receive one of three conditioning chemotherapy and radiation regimens before transplant to prepare their bodies. They are randomized to receive either naive T-cell depleted stem cells or unmodified bone marrow on transplant day. After transplant, all patients receive medications tacrolimus and methotrexate to help prevent graft-versus-host disease. Procedures such as echocardiography and cerebrospinal fluid collection are done at baseline, with blood and bone marrow samples collected throughout the trial. Participants are monitored closely after treatment with follow-up visits at days 28, 56, 90, 180, 270, and 365, and then every 3 months up to 24 months. Researchers assess how well stem cells engraft, the occurrence of graft-versus-host disease, survival without relapse, and medication use. Safety and feasibility of the treatments are also evaluated. The study lasts up to two years with thorough ongoing clinical and laboratory assessments.

Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant