Trial Information

Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study

OBJECTIVES: I. Determine whether a delayed multidrug intensification can be given in
conjunction with methotrexate and leucovorin calcium rescue consolidation therapy in
children with average risk acute lymphocytic leukemia. II. Determine the feasibility of
delivering 6 courses of this therapy in these patients.

OUTLINE: This is a multicenter study. Induction: Patients receive oral dexamethasone twice
daily on days 1-29, vincristine IV on days 1, 8, 15, and 22, and asparaginase
intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients receive methotrexate
intrathecally (IT) on days 1 and 15. CNS 2 and 3 patients also receive methotrexate IT on
days 8 and 22. Patients with M1 bone marrow receive oral mercaptopurine daily beginning on
day 29. Patients with M2 bone marrow on day 29 receive oral dexamethasone twice daily on
days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and
asparaginase IM on days 29, 32, 36, and 39. Patients with M3 bone marrow on day 29 or M2 or
M3 bone marrow on day 43 are taken off study. Consolidation: Patients receive methotrexate
IV over 4 hours once a week during weeks 7, 10, 13, 24, 27, and 30, oral leucovorin calcium
every 6 hours for 5 doses beginning 42 hours after the start of methotrexate infusion,
methotrexate IT during weeks 5, 9, 12, 16, 20, 21, and 29, asparaginase IM 3 times weekly
during weeks 16 and 17, and oral mercaptopurine daily during weeks 5-14 and from week 24
until the end of consolidation. Patients receive oral dexamethasone twice daily during weeks
8, 16-18, and 28, vincristine IV on day 1 during weeks 8, 9, 16, 17, 18, 28, and 29,
daunorubicin IV on day 1 during weeks 16, 17, and 18, cyclophosphamide IV over 30 minutes on
day 1 during week 20, cytarabine IV or subcutaneously on days 2-5 during weeks 20 and 21,
and oral thioguanine daily during weeks 20 and 21. Intensive continuation: Patients receive
oral methotrexate every 6 hours for 24 hours during weeks 1, 3, 5, and 7, oral
mercaptopurine daily, and oral leucovorin calcium every 12 hours for 1 day beginning 48
hours after the start of oral methotrexate. Patients also receive methotrexate IT during
week 8, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days
beginning with vincristine. Treatment repeats every 8 weeks for 6 courses. Another
continuation: Patients receive oral methotrexate once weekly except during the week of
methotrexate IT administration, oral mercaptopurine daily, methotrexate IT every 8 weeks,
vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days
beginning with vincristine. Treatment continues for up to 130 weeks in the absence of
disease progression or unacceptable toxicity. Patients are followed every 6 months for 4
years and then annually until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.