Allogeneic Transplant for Hematological Malignancy
The chemotherapy (cyclophosphamide and busulfan) is given with the intent of destroying the
bone marrow, eliminating any cancerous and preparing for the transplant of the donor's blood
stem cells by suppressing the immune system.
l. Ten days before the transplant (Day 10), subjects will be admitted to the bone marrow
transplant unit and placed in isolation to reduce exposure to infections. Isolation will be
continued until adequate numbers of cells are present in the blood to fight infection.
2. On day -9, -8, -7, -6 busulfan is given.
3. On day -5, -4, -3, -2 cyclophosphamide is given.
4. On day -1 no therapy is given (day of rest).
5. On day 0 the donor stem cells are given intravenously. Additional cells may be given on
day +1 or 2 as needed.
Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce
exposure to infectious agents. During this time, they will receive the preparative
treatment outlined above. Once they have received the preparative regimen, stem cells will
be obtained from the donor and given intravenously.
The new stem cells will replace the bone marrow that was damaged by the treatment for the
Isolation will be continued until adequate numbers of cells are present in the blood to
fight infection. Subjects will then be transferred from the bone marrow transplant unit and
discharged from the hospital when medically ready. Subjects will be expected to return for
follow-up to the bone marrow transplant clinic at specific dates as determined by their
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
Long-term (1 and 2 year)
Daniel Weisdorf, MD
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
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