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Largest study of unrelated bone marrow transplantation for leukemia serves as benchmark

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Hey Folks,

I am back from a nice vacation on board a boat in Lake Champlain, and I am

lucky enough to be able to plan a second vacation of the same genre at the

end of this month.

Hope everyone has been well.

Here's an interesting article regarding BMT's.

Cheers,

Cheryl-Anne

Largest study of unrelated bone marrow transplantation for leukemia serves

as benchmark

Multi-institutional study addresses critical GVHD complication

Together with 16 other institutions in the United States, University of

Minnesota researchers led the largest study to date in patients with

leukemia and related disorders undergoing bone marrow transplantation from

unrelated donors. The study was designed to determine whether one of two

general approaches to prevent graft-versus-host-disease (GVHD), a

potentially lethal complication, might result in improved survival.

While the trial demonstrated similar survival rates, the study was the most

comprehensive to date, evaluating various clinical outcomes, resource

utilization, costs, and health quality of life. The study, published in the

Aug. 3, 2005 online issue of The Lancet, will likely serve as the benchmark

for all future studies in this patient population.

Graft-versus-host-disease is a common complication after bone marrow

transplantation in which the immune cells from the donated marrow attack the

body of the patient who received the transplant. Severity ranges from mild

to life threatening, and the disease and its treatment can have a profound

effect on quality of life.

The two primary strategies for preventing GVHD, the removal of T-cells (the

cell that causes GVHD) and immunosuppressive drug therapy (suppression of

T-cell function), were studied in this trial. While the primary aim of the

study was to demonstrate whether one approach might be better than the other

in terms of disease-free survival three years after transplantation, the

study also systematically compared the incidence of various complications

(GVHD, graft failure, therapy-related side effects, disease recurrence) as

well as utilization of blood products, nutritional supplementation, number

of admissions to the hospital and intensive care unit, hospital costs, and

health quality of life.

" While the T-cell depletion approach was very effective in reducing the risk

of GVHD, a higher risk of viral infection in general and higher risk of

disease recurrence specifically in patients with chronic myelogenous

leukemia, eliminated the potential benefit of reduced GVHD, " , " said E.

Wagner, M.D., professor of pediatrics and scientific director of clinical

research, Blood and Marrow Transplantation Program and Stem Cell Institute,

and lead author of the study. " Overall, we observed no differences in

survival at three years and no appreciable differences in cost or quality of

life. "

These results counter what investigators might have guessed and reflect the

critical importance of performing large randomized trials. " Prior to this

study, colleagues promoting T-cell depletion, like myself, predicted that

T-cell depletion would have offered a better chance of survival, " Wagner

said. " What is abundantly clear is that T-cell depletion and GVHD prevention

is only one step in figuring out how to improve upon the chance of cure in

unrelated marrow transplant patients. The next hurdle is to find ways to fix

the crippled immune system. "

Despite the lack of evidence that one approach was better than the other,

" the results clearly point out the limitations of bone marrow transplants, "

Wagner said. However, he added that the methodological approaches used and

study results will be valuable benchmarks for future studies of novel

treatments for leukemias and other blood-related cancers.

###

The study was sponsored by the National Heart, Lung and Blood Institute.

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