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A Phase I Study of WT1-Sensitized T cells for Residual or Relapsed Leukemia after Allogeneic Hematopoietic Progenitor Cell Transplantation

[Protocol 07-055]

Full Title :

A PHASE I DOSE ESCALATION TRIAL OF WT1-SPECIFIC T CELLS FOR RESIDUAL OR RELAPSED LEUKEMIA AFTER ALLOGENEIC HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION

Purpose :

Stem cell transplantation is a treatment for leukemia or myelodysplastic syndrome (MDS). However, in some patients, leukemia or MDS cells remain in the body or come back after disappearing, despite the stem cell transplant.

In this study, researchers have taken a protein called the Wilms' Tumor Protein (WT1) -- which can be found in some, but not all, leukemic cells -- and, in the laboratory, they have grown immune cells (T cells, a type of white cell) which are sensitized to that protein.

The purpose of this study is to found out if, in patients with leukemia that has the WT1 protein, the administration of "WT1-sensitized T cells" grown from an HLA-matched donor can be performed safely. Researchers want to learn whether the WT1-sensitized T cells can attack the protein and kill the leukemia or MDS cells. They also hope to learn what the WT1-sensitized T cells do to each patient's disease.

Eligibility :

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

• Patients must have a confirmed diagnosis of leukemia or MDS that has persisted or returned after stem cell transplantation. Patients who are going to have a stem cell transplant and whose disease has a high risk of recurring may also be eligible.
• Patients' leukemia or MDS blasts must express the WT1 protein.
• Patients must have an HLA-matched donor.

For more information and to inquire about eligibility for this study, please contact Dr. Richard O'Reilly at 212-639-5957.