A Study of T-Cell Depleted Allogeneic Stem Cell Transplantation Using a Low-Intensity Conditioning for Patients with Myeloid Cancers and Aplastic Anemia

Full Title

IIT: Allogeneic Hematopoietic Stem Cell Transplantation of an a/ß+ T-Lymphocyte Depleted Grafts Conditioned with a Reduced Intensity Regimen in Patients with Myeloid Malignancies

Purpose

Patients with bone marrow disease, such as aplastic anemia, or cancer of the bone marrow, such as acute leukemia, myelodysplastic syndrome, myeloproliferative disorders, chronic myelogenous leukemia, or chronic myelomonocytic leukemia, may need a stem cell transplant from a donor (allogeneic transplant) if chemotherapy is not enough to control the disease. The chemotherapy and/or radiation therapy used to prepare for transplant, called a “conditioning” regimen, can vary in its intensity. The higher the intensity, the more side effects the patient is exposed to. One complication that is unique to stem cell transplantation is graft-versus-host disease (GvHD), where white blood cells, called T cells, from the donated stem cell transplant attack tissues of the recipient.

In this study, researchers are evaluating a low-intensity conditioning regimen for patients with myeloid cancers or aplastic anemia who need an allogeneic stem cell transplant. Patients will then receive a T-cell depleted transplant, where T cells are removed, using a new method, from the donated transplant to reduce the risk of GvHD. The goal is to be able to provide a more tolerable transplant that is as effective for controlling cancer growth as the conventional approach.

Eligibility

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

  • Patients must have acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, chronic myelogenous leukemia, or aplastic anemia and require an allogeneic stem cell transplant.
  • Patients must have a matched stem cell donor.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roni Tamari at 212-639-5987.

Protocol

17-639

Phase

Pilot

Investigator