Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS

Summary

This study will evaluate the safety and effectiveness of stem cell transplantation in which the donors T lymphocytes have undergone "selective depletion." Certain patients with cancers of the blood undergo transplantation of donated stem cells to generate new and normally functioning bone marrow. In addition to producing the new bone marrow, the donor's T-lymphocytes also fight any tumor cells that might have remained in the body. This attack on tumor cells is called a "graft-versus-leukemia" (GVL) effect. However, another type of T-lymphocyte from the donor may cause what is called "graft-versus-host-disease" (GVHD), in which the donor cells recognize the patient's cells as foreign and mount an immune response to reject them. Selective depletion is a technique that was developed to remove the T-lymphocytes that cause harmful GVHD, while keeping those that produce the desirable GVL effect.

Timeline

Start

2001-05

Primary completion

2008-02

Completion

2008-02

Publications

• Background Barrett J, Solomon S. The transition from bench to bedside: lessons learned in the creation of a new T-cell product for the clinic. Cytotherapy. 2004;6(6):593-5. doi: 10.1080/14653240410011936.
• Background Solomon SR, Tran T, Carter CS, Donnelly S, Hensel N, Schindler J, Bahceci E, Ghetie V, Michalek J, Mavroudis D, Read EJ, Vitetta ES, Barrett AJ. Optimized clinical-scale culture conditions for ex vivo selective depletion of host-reactive donor lymphocytes: a strategy for GvHD prophylaxis in allogeneic PBSC transplantation. Cytotherapy. 2002;4(5):395-406. doi: 10.1080/146532402320775982.
• Background Mielke S, Solomon SR, Barrett AJ. Selective depletion strategies in allogeneic stem cell transplantation. Cytotherapy. 2005;7(2):109-15. doi: 10.1080/14653240510018172.
• Results Solomon SR, Mielke S, Savani BN, Montero A, Wisch L, Childs R, Hensel N, Schindler J, Ghetie V, Leitman SF, Mai T, Carter CS, Kurlander R, Read EJ, Vitetta ES, Barrett AJ. Selective depletion of alloreactive donor lymphocytes: a novel method to reduce the severity of graft-versus-host disease in older patients undergoing matched sibling donor stem cell transplantation. Blood. 2005 Aug 1;106(3):1123-9. doi: 10.1182/blood-2005-01-0393. Epub 2005 Apr 7.

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