Reduction of Graft-Versus-Host Disease Mini-Transplants:Trial Enrolling Patients

Reduction of Graft-Versus-Host Disease in Mini-Transplants:National Institutes Health Clinical Trial Enrolling Patients

The National Institutes of Health is currently recruiting patients for a clinical trial to evaluate a novel approach in reducing the risk of graft-versus-host disease in elderly patients with certain hematological (blood) malignancies who are to undergo a mini allogeneic stem cell transplant.

Many patients with certain hematological malignancies can be cured of their disease with an allogeneic stem cell transplant. An allogeneic stem cell transplant is a procedure in which a patient undergoes high doses of chemotherapy and/or radiation therapy in an attempt to kill the maximum number of cancer cells. These high doses, however, also kill the stem cells in the bone marrow, which are immature blood cells that form into the three different major types of blood cells: white blood cells; which fight infection, red blood cells; which carry oxygen to cells and platelets; which aid the blood in clotting. In an attempt to restore the depleted levels of stem cells following high doses of therapy, patients may receive an infusion of their own stem cells (autologous) that were collected prior to therapy, or an infusion of a donors stem cells (allogeneic).

One benefit of an allogeneic stem cell transplant is that the donor cells which mature into white blood cells may mount an immune attack against the patients cancer cells, called the graft-versus-leukemia effect. However, the donor cells may also mount an immune attack against the patients healthy tissues, called graft-versus-host disease. Recently, researchers have been evaluating mini stem cell transplants in which more moderate doses of therapy are given prior to stem cell infusion. Mini-transplants rely on the graft-versus-leukemia effect to eradicate the remaining cancer cells. Since many patients who would benefit from an allogeneic stem cell transplant may not be able to tolerate the procedure with the high doses of therapy utilized, mini-transplants may provide these patients an alternative treatment option. Because mini-transplants utilize donor cells, the possibility of graft-versus-host disease still exists.

Since graft-versus-host disease can be a life threatening and/or life debilitating condition, researchers are now investigating options to reduce the incidence and/or severity of graft-versus-host disease while maintaining efficacy of an allogeneic stem cell transplant. One approach being evaluated is the elimination of a specific type of immune cell. The process works as follows: specific cells are collected from the patient and mixed with donor immune cells. The donor immune cells that react against the patient cells are selectively eliminated. Researchers believe the donor immune cells that are activated against the patient cells may be responsible, at least in part, for causing graft-versus-host disease.

Since graft-versus-host disease can be a life threatening and/or life debilitating condition, researchers are now investigating options to reduce the incidence and/or severity of graft-versus-host disease while maintaining efficacy of an allogeneic stem cell transplant. One approach being evaluated is the elimination of a specific type of immune cell. The process works as follows: specific cells are collected from the patient and mixed with donor immune cells. The donor immune cells that react against the patient cells are selectively eliminated. Researchers believe the donor immune cells that are activated against the patient cells may be responsible, at least in part, for causing graft-versus-host disease.

This clinical trial is utilizing a mini allogeneic transplant approach in which the donor cells believed to be responsible for graft-versus-host disease are eliminated. Patients must be between the ages of 55 and 75, have an available family donor and have high-risk myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, non-Hodgkins lymphoma or Hodgkins disease.

Patients who are interested in participating in this clinical trial may wish to speak with their physician regarding the risks and benefits of this procedure. Further information may be obtained at the National Institutes of Health by e-mailing solomons@nhlbi.nih.gov.

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