Stem Cell Transplant for Hematological Malignancy

Preparative regimen using total body irradiation (TBI) and cyclophosphamide:

1. on day -6 and -5: cyclophosphamide is given,

2. on day -4, -3, -2, and -1: TBI is given,

3. on day 0: stem cell or bone marrow is infused.

Alternate preparative therapy for patients not able to receive TBI

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.

Transplant:

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
cancer.

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
physician.

Inclusion Criteria:

- Donor will be <75 years of age and in good health.

- Recipients will be < or = 55 years, will have normal organ function (excluding bone
marrow) and will have a Karnofsky activity assessment > or = 90%.

- Recipients with related or unrelated donor matched at the HLA A, B, DRB1 loci, or
mismatched related or unrelated (if < 35 years old) at a single HLA A, B, DRB1 locus.

- Recipients will be eligible in one of the following disease categories

- Chronic myelogenous leukemia in accelerated phase or in post blast crisis second or
greater chronic phase; or in chronic phase but intolerant of or resistant to tyrosine
kinase inhibitors.

- Acute myelocytic leukemia in first or greater remission, or first, second or third
relapse.

- Acute lymphocytic leukemia in the 2nd or greater bone marrow remission.

- High risk children will be transplanted in first remission if they meet criteria

- Myelodysplastic syndrome.

- Myeloproliferative Diseases - (i.e. myelofibrosis, chronic myelomonocytic leukemia
(CMML))

- Juvenile myelomonocytic leukemia

- Chronic lymphocytic leukemia

- Advanced non-Hodgkin's (NHL).

- Advanced Hodgkin's disease beyond PR2 (> CR3, > PR3).

- Multiple Myeloma after initial therapy.

- Donors and recipients signed informed consent

Exclusion Criteria

donors and recipients should meet the following test criteria.

- required for donors:

- anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies,
pre-priming.

- CBC, platelet count each day of apheresis, day 0 (or 1 or 2 as needed)

- required for recipients:

- anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies,
pre-transplant.