A Phase II Study of Palifermin with or without Leuprolide After T-Cell-Depleted Allogeneic Stem Cell Transplantation

An infusion of stem cells from a donor — an allogeneic stem cell transplant — is one way of treating hematologic cancers. One potential complication of stem cell transplantation is graft-versus-host disease (GvHD). GvHD is caused when cells from the donor view the recipient’s cells as foreign, resulting in symptoms such as rash, diarrhea, nausea, and vomiting, among others. Removing the T cells (T-cell depletion) from the donor’s stem cell transplant lowers the risk of GvHD.

One downside of T-cell-depleted transplants, however, is an elevated risk of infection in the recipient. In this study, researchers want to see if the drug palifermin given with or without leuprolide can protect against infection and help the patient’s immune system recover more quickly. This approach will be evaluated in patients with hematologic cancers for whom a stem cell transplant offers the best chance of a cure.

Palifermin is already used for decreasing mouth sores after allogeneic transplantation. Leuprolide is frequently used to decrease menstrual bleeding in women who have had a transplant. Patients in this study will receive palifermin alone, palifermin plus leuprolide, or a transplant without either drug.