A Phase II Study of T-Cell Depleted Stem Cell Boost for Adults and Children with Low Blood Counts After Allogeneic Stem Cell Transplantation

Full Title

Phase II Trial of T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation

Purpose

In some patients who receive stem cells from a donor, there is poor “engraftment.” This means the new stem cells are not establishing a new blood system for the patient as well as they should. Patients with such poor graft function have low blood counts, such as too few red and white blood cells and not enough blood-clotting cells called platelets. They may need medications and transfusions, and have a high risk of bleeding and infections.

In this study, researchers are evaluating a new treatment for these patients. It involves giving them more stem cells from their original donor. However, the donor’s T cells will be removed before the stem cells are given to the patient. This is done to reduce the risk of a complication called graft-versus-host disease (GVHD), in which the T cells from the donor attack the patient’s body tissues and cause inflammation. Doctors hope that giving patients a single “boost” of T-cell-depleted stem cells from the donor will improve their blood cell counts without causing GVHD.

Eligibility

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

  • Patients must be experiencing poor graft function following receipt of stem cells from a donor.
  • This study is for patients of all ages, including children.

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

Protocol

14-228

Phase

II

Investigator

Locations