18.0 SUMMARY STATEMENT; PART 1 
BONE MARROW TRANSPLANTATION 
You are (your child is) in remission from acute myeloid leukemia (AML). But there is 
about a 65 % chance that the leukemia will return. Once AML comes back it is very hard 
to treat. We believe that the best way to prevent this is to give you (your child) very high 
doses of chemotherapy to kill any leukemia cells that may be left. Then, a bone marrow 
transplant will be done using your (your child's) own bone marrow. This is necessary 
because the chemotherapy also kills normal cells in the marrow. 
STUDIES BEFORE TREATMENT 
To make sure the transplant is safe, we will test your (your child's) blood for certain viruses. 
These include hepatitis B, which causes liver damage; cytomegalovirus, which causes lung 
damage; and HIV, which causes AIDS. If these tests show that any of the viruses are there 
we will discuss with you how they might affect your treatment. We will also do other tests 
to help us plan your transplant. 
MARROW HARVEST 
Before the high-dose chemotherapy starts, we will remove a small part of your (your 
child's) bone marrow from the hip bone. This will be done in the operating room under 
general anesthesia. You (your child) will not feel anything when the marrow is taken. 
There may be some pain later. You (your child) will be given medicine for the pain. 
HIGH-DOSE CHEMOTHERAPY 
Soon after bone marrow harvest, chemotherapy will start. A drug called busulfan will be 
given by mouth four times a day for four days. The drug Cytoxan will be started on the day 
after the last dose of Busulfan. It will be given by vein (IV) for four days. If there are 
leukemia cells in the spinal fluid before treatment, the drug methotrexate will be given in 
the spinal fluid every 3 days until the cells are killed. The maximum number of spinal taps 
will be 5. 
BONE MARROW TRANSPLANT 
You (your child) will rest for one day after the chemotherapy. Then the bone marrow that 
was taken out before will be put back through an IV catheter. Bone marrow aspirates and 
biopsies will be done on days 21 and 32 after the transplant. Bone marrow aspirates will 
also be done after you are (your child is) well to see how the graft is working. We will take 
these samples every 6 months for 2 years and then once a year for 2 years. Any marrow 
that you do not need (your child does not need) may be used for research. 
CONFIDENTIALITY 
Your (your child's) case will be treated in complete confidence, unless you specifically agree 
otherwise. However, approved people from Government agencies may review the charts. 
SIDE EFFECTS 
The drugs in this study will cause some bad side effects. Doctors will watch you (your child) 
carefully to prevent these effects or make them less severe. You (your child) will receive 
a drug called Mesna to prevent bleeding from the bladder, and Dilantin to stop possible 
seizures (fits). Bone marrow transfusion can also produce very serious side effects. The 
busulfan and Cytoxan destroy normal bone marrow and can cause severe infections and 
bleeding. You will need antibiotics, blood transfusions and possibly a medicine called 
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