T Cell-Depleted Stem Cell Transplant for Leukemia

This trial explores a new method to prevent graft-versus-host disease, a common complication after donor stem cell transplants in children and young adults with certain blood cancers like leukemia. The researchers focus on removing a specific type of T cell from donor cells before the transplant to determine if it reduces the risk of this complication. Participants will receive various combinations of chemotherapy and radiation treatments, followed by the stem cell transplant. Those with blood cancers such as acute lymphoblastic leukemia (with less than 5% cancer cells in the bone marrow) and identified as transplant candidates might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in care.

The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Research has shown that removing certain immune cells, called naive T cells, from stem cell transplants may help prevent chronic graft-versus-host disease (GVHD), where donor cells attack the patient's body. Studies have found that this method does not increase the risk of infections or cancer recurrence. Notably, about 78% of patients remained alive two years after receiving this treatment, indicating it is generally safe and well-tolerated.

The other treatments, including the drugs busulfan, cyclophosphamide, fludarabine, methotrexate, tacrolimus, and thiotepa, are standard in stem cell transplants. These drugs are known to be safe and have FDA approval for other uses. While they can cause side effects, they are generally safe when administered under a doctor's care.

Researchers are excited about these treatments for leukemia because they explore innovative approaches to stem cell transplantation. Unlike traditional methods, one approach uses naive T cell-depleted peripheral blood stem cells (PBSCs), potentially reducing the risk of graft-versus-host disease (GVHD) by eliminating mature T cells that can attack the patient's tissues. The other approach involves unmanipulated T cell-replete bone marrow (BM), which maintains the natural T cell content, potentially enhancing immune recovery. Both methods include targeted conditioning regimens and GVHD prophylaxis aiming to improve patient outcomes and treatment tolerance.

Research has shown that removing certain T cells, known as naive T cells, can help prevent chronic graft-versus-host disease (GVHD) in patients receiving stem cell transplants for blood cancers. In this trial, one group of participants will receive naive T-cell depleted peripheral blood stem cells (PBSCs). Previous studies have demonstrated a 78% survival rate after two years, indicating potential effectiveness. This process involves removing specific T cells from the donor's cells to reduce the risk of the donor's cells attacking the patient's healthy tissues. Tested in patients with acute leukemia, this method has not resulted in higher rates of infection or cancer recurrence. The goal is to make stem cell transplants safer and more effective by reducing complications like GVHD.¹²⁶⁷⁸