Leukemia Clinical Trial
Official title:
Low Intensity Preparative Regimen Followed by HLA-Matched, Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematologic Malignancies in Older Adults
Diseases such as leukemia, lymphoma, and multiple myeloma fall into the category of blood
cancers. Some of these conditions can now be cured by bone marrow transplantation (BMT). The
ability of BMT to cure these conditions has been credited to the use of high doses of
chemotherapy, radiation therapy, and the antileukemia effect of the transplant.
Because the effectiveness of BMT relies on the use of high doses of chemotherapy and total
body irradiation (TBI), it is a therapy associated with toxic side effects. These side
effects are often deadly and have limited BMT for use in patients under the age of 55.
In this study researchers plan to treat older patients between the ages of 55 to 75 years
with blood cell transplants taken from donors who are genetically matched relatives of the
patient. In order to decrease the toxic side effects associated with the transplant,
researchers will not use chemoradiotherapy. Instead they plan to use intensive
immunosuppressive therapy and allow the transplanted cells to take effect.
Patients with adult leukemias, non-Hodgkin's lymphoma and multiple myeloma, can now be cured
by allogeneic bone marrow transplantation (BMT). This curative effect has been ascribed to
the use of high dose chemoradiotherapy and the antileukemia effect of the graft.
The assumption that BMT relies on the myeloablative effect of high dose chemotherapy and
total body irradiation (TBI), has largely restricted allogeneic bone marrow transplantation
in adults to those under the age of 55 years. Toxicity related mortality increases
progressively with age and although some transplant centers carry out BMT in patients up to
the age of 60 years, it is generally accepted that treatment related mortality prohibits the
use of allogeneic bone marrow transplantation in patients beyond the age of 55 years.
Several in vitro studies have demonstrated the existence of donor-derived CD4 and CD8
positive lymphocytes with specific reactivity for the patients leukemia and a potent graft
versus leukemia (GVL) effect. This GVL effect is best seen in patients with relapse CML after
bone marrow transplantation where a single infusion of donor lymphocytes can induce complete
remission.
In this protocol, we treat older patients between the ages of 55 to 71 years with hematologic
disorders with an allogeneic stem cell transplant from an HLA identical sibling, using
intensive immunosuppressive regimen without myeloablation in attempts to decrease the
transplant related toxicity while preserving the antileukemia effect of the graft. The low
intensity nonmyeloablative conditioning regimen will provide adequate immunosuppression to
allow stem cell and lymphocyte engraftment. T-cell replete, donor-derived, granulocyte colony
stimulating factor (G-CSF) mobilized peripheral blood stem cells (PBSC) will be used to
establish hematopoietic and lymphoid immune reconstitution. We will add back lymphocytes in
patients with less than 75% donor marrow chimerism as an attempt to prevent graft rejection.
The end points of this study are engraftment, degree of donor-host chimerism, incidence of
acute and chronic GVHD, transplant related morbidity and mortality as well as survival.
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