Clinical observations, interventions, and therapeutic trials

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Supplementary Table 2. Treatment plan for infant ALL with a germline MLL gene
Phase and drug
Delivery,
duration
Dosage*
Dose schedule
Induction
DEX
IV
10 mg/m2
PSL
PO or IV
60 mg/m2
VCR
IV
0.05 mg/kg
CPA
IV , 1-2 hr
1,200 mg/m2
DXR
IV, 1 hr
25 mg/m2
ASP
IV, 3-4 hr
10,000 U/m2
TIT
Age-adjusted†
VP-16
IV, 1-2 hr
100 mg/m2
Ara-C
IV, 4 hr
500 mg/m2
Consolidation and central nervous system prophylaxis
MTX
IV, 24 hr
3 g/m2
Leucovorin
IV
15 mg/m2
TIT
Age-adjusted†
CPA
IV, 1-2 hr
500 mg/m2
ASP
IV or IM
10,000 U/m2
PSL
PO or IV
60 mg/m2
Intensification
VCR
IV
0.05 mg/kg
DNR
IV
25 mg/m2
Ara-C
IV, 1 hr
60 mg/m2
6-MP
PO
75 mg/m2
TIT
Age-adjusted†
Reinduction: same as induction
Maintenance‡
Regimen A
6-MP
PO
75 mg/m2
MTX
PO
30 mg/m2
VP-16
IV, 1-2 hr
150 mg/m2
Ara-C
IV, 4 hr
200 mg/m2
Regimen B
6-MP
PO
75 mg/m2
MTX
PO
30 mg/m2
PSL
PO
60 mg/m2
VCR
IV
0.05 mg/kg
MTX
IV, 5hr
300 mg/m2
TIT
Age-adjusted†
Days 1-14
Days 15-28
Days 1, 8, 15, 22
Day 2
Days 3, 5
Days 16, 18, 20, 23, 25, 27
Days 1, 15, 29
Days 29-32
Days 29-32
Days 1, 15, 29
36 hr after start of MTX, 7 times
Days 1, 15, 29
Days 2, 16, 30
Days 2, 16, 30
Days 1-3
Days 1, 8, 15
Days 1, 8, 15
Days 2-7, Days 9-14
Days 1-14
Days 1, 15
Days 1-14
Days 1, 8
Day 14
Day 14
Days 1-14
Days 1, 8
Days 15-28
Days 15, 22, 29
Day 15
Every 6 weeks
DEX, dexamethasone; PSL, prednisolone; VCR, vincristine; CPA, cyclophosphamide;
DXR, doxorubicin; ASP, L-asparaginase; TIT, triple intrathecal therapy; VP-16, etoposide;
Ara-C, cytarabine; MTX, methotrexate; IV, intravenously; PO, orally; hr, hour; IM,
intramuscularly. The dose of each drug except VCR was reduced by one third in patients
younger than 2 months and by one fourth in those 2 to 4 months of age.
* Doses were calculated according to body weight in MLL96 study.
† Doses were adjusted according to the patient’s age at administration as follows: 90 days
old or younger, MTX 3 mg, hydrocortisone (HDC) 10 mg, Ara-C 6 mg; younger than 1 year
old, MTX 6 mg, HDC 10 mg, Ara-C 12 mg; 1 year and older, MTX 8 mg, HDC 15 mg,
Ara-C 20 mg.
‡ Each cycle consisted of two courses of Regimen A followed by Regimen B
(each regimen was given over 2 weeks). The 12-week course was repeated 4 times.
The total period of maintenance therapy was nearly 56 weeks.
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