A Phase II Study of a New Approach to Prevent GVHD after Stem Cell Transplantation for Patients with Bone Marrow and Lymph Node Cancers Using Mismatched Donors

Full Title

IIT: Allogeneic Hematopoietic Cell Transplantation Using a/ß+ T-lymphocyte Depleted Grafts from HLA Mismatched Donors

Purpose

A bone marrow transplant (sometimes called “allogeneic stem cell transplant”) is one way of treating blood and lymph node 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 T cells in the lab after the stem cells are taken from the donor, but before they are given to the patient, helps stop GVHD, but may slow down recovery of the immune system and increase the risk of infection after transplant. Some T cells are more likely to cause GVHD than others. T cells with the alpha/beta receptor (“alpha/beta T cells”) are associated with the development of GVHD. Patients in this study will only have the alpha/beta T cells removed from their donor’s stem cells, allowing patients to receive other types of immune cells.

The goal of this study is to determine if this way of preventing GVHD is effective in patients receiving a stem cell transplant and if it will result in a decrease in infections after the transplant.

Eligibility

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

  • Patients must have a cancer of the blood, bone marrow or lymph nodes that requires treatment with a stem cell transplant from a HLA mismatched donor. These cancers include acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndromes, chronic myelomonocytic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, or Hodgkin lymphoma.
  • This study is for patients whose donors are partially matched relatives (“haploidentical”) or who have mismatched unrelated donors.
  • This study is open to pediatric and adult patients up to age 65.

For more information about this study and to inquire about eligibility, please contact Dr. Brian Shaffer at 212-639-2212.

Protocol

18-224

Phase

II

Investigator