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

Protocol
12-077
Full Title
An Open Label Randomized Phase II Study of Palifermin With Leuprolide Acetate Versus Control for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation
Phase
II
Purpose

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.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have acute myeloid or lymphocytic leukemia, chronic myelogenous leukemia, high-risk myelodysplastic syndrome, or non-Hodgkin lymphoma. A stem cell transplant must offer their best chance for a cure.
  • Patients must have a donor who is able to donate stem cells for transplantation.
  • Patients may not have had allogeneic or autologous stem cell transplantation within 6 months of entering the study.
  • This study is open to patients who are at least age 18 and no older than 60.

For more information about this study and to inquire about eligibility, please contact Dr. Jenna Goldberg at 212-639-4828.

Disease(s)
Blood & Marrow Stem Cell Transplantation: Post-Transplant
Hematology: Myelodysplastic Syndrome
Leukemia: Acute Lymphoblastic Leukemia
Leukemia: Acute Myelocytic Leukemia
Leukemia: Chronic Myelocytic Leukemia
Lymphoma: Non-Hodgkin's Lymphoma
Locations