11.1.2 Cytogenetic analysis performed on the pre-harvest bone marrow must 
be normal. 
11.1.3 Cell harvest must be sufficient for marrow reconstitution (cell yield 
must be greater than 4 x 10 8 nucleated cells/kg). This should yield 
sufficient cells for bone marrow transplantation even if the cells taken 
for vector marking/purging cannot be used. 
11.2 Patients without CNS leukemia will receive busulfan (1 mg/kg of ideal or 
actual body weight whichever is less) orally every 6 hours for 16 doses on days 
-9, -8, -7, -6, followed by cyclophosphamide (50 mg/kg/dose) with Mesna on 
days -5, -4, -3, -2. Patients will also receive dilantin to prevent busulfan- 
induced seizures* Autologous marrow is infused 48 hours later. 
Protocol dav 
Treatment 
10 
Begin Dilantin (5 mg/kg q 6 h x 8 doses) then 
5 mg/kg/day to day -4 
-9 
BU 
-8 
BU 
1 mg/kg, q 6 hr x 16 doses 
-7 
BU 
-6 
BU 
-5 
CTX 
50 mg/kg 
+ MESNA 
-4 
CTX 
50 mg/kg 
+ MESNA (stop Dilantin) 
-3 
CTX 
50 mg/kg 
+ MESNA 
-2 
CTX 
50 mg/kg 
+ MESNA 
-1 
REST 
0 
Autologous 
bone marrow reinfusion 
11.3 Patients with CNS disease documented by lumbar puncture on pretransplant 
evaluation, will receive IT methotrexate (dose below) every third day until 
clear x 2 (minimum number = 3, maximum number = 5). Three days after 
the last lumbar puncture patients will begin BU treatment as outlined above. 
If the IT methotrexate results in headache, photophobia, or neck stiffness then 
20 mg of hydrocortisone will be added. 
MTX (mgl 
6 
8 
10 
12 
Patients with a history of CNS disease at any time in the past (including 
immediately pre-transplant) will also receive 5 lumbar punctures with IT 
Age (yr) 
<1 
1-2 
2-3 
>3 
Recombinant DNA Research, Volume 17 
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