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Stem Cell Transplantation and T-Cell Add-Back to Treat Bone Marrow Malignances

National Heart, Lung, and Blood Institute (NHLBI) · 2002
ClinicalTrials.gov · Datasets · License: Public Domain · 2002
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curegraft-versus-host-diseaseimmunosuppressionleukemiaradiation
This study will evaluate the safety and effectiveness of stem cell transplantation in which the donor s T cells (a type of lymphocyte, or white blood cell) have been removed and then added back. Certain patients with bone marrow malignancies undergo transplantation of donated stem cells (cells produced by the bone marrow that mature into the different blood components white cells, red cells and platelets) to generate new and normally functioning bone marrow. However, T-cells from the donor may see the patient s cells as foreign and mount an immune response to reject them, causing what is called graft-versus-host-disease (GVHD). Therefore, in this study, T-cells are removed from the donor cells to prevent this complication. Nevertheless, there are disadvantages of removing the T-cells, since they are important in fighting viral infections as well as any remaining malignant cells. The attack against the malignant cells is called a graft-versus-leukemia effect. Therefore, donor T cells are given to the patient (added back) later (45 and 100 days after the transplant) when they can provide needed immunity with less risk of causing GVHD. Patients between 10 and 55 years of age with chronic myelogenous leukemia, acute lymphoblastic leukemia, acute myelogenous leukemia, a myelodysplastic syndrome, myeloproliferative disorders, or chronic lymphocytic leukemia may be eligible for this study. Prospective participants and their donors are screened with a medical history and physical examination, blood tests (including a test to match for genetic compatibility), breathing tests, chest and sinus X-rays, and tests of heart function. They also undergo a bone marrow biopsy and aspiration. For this procedure, done under local anesthetic, about a tablespoon of bone marrow is withdrawn through a needle inserted into the hipbone. Participants may undergo apheresis to collect lymphocytes for research studies. This procedure involves collecting blood through a needle in the arm, simila
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