NCT00165178 - Treatment of Acute Lymphoblastic Leukemia in Children | Biotech Hunter

Enrollment

498

Participants

Timeline

Start Date

September 30, 2000

Primary Completion Date

December 31, 2004

Study Completion Date

May 31, 2011

Conditions

Acute Lymphoblastic Leukemia

Interventions

DRUG

prednisone

Induction Phase: Given orally or intravenously Days 0-28 Intensification Phase: Given orally Days 1-5 of each cycle Continuation Phase: Given orally Days 1-5 of each cycle

DRUG

dexamethasone

Intensification Phase: Given orally days 1-5 of each cycle Continuation Phase: Given orally days 1-5 pf each cycle

DRUG

doxorubicin

Induction Phase: Intravenously on Days 0,1 Intensification Phase: Intravenously on Day 1 of each cycle

DRUG

E. coli asparaginase

Intensification Phase: In the muscle weekly. Dose will vary

DRUG

vincristine

Induction: Intravenously on days 0, 7, 14, 21 MLL Intensification Phase: Intravenously on Days 1, 8, 15, 22 CNS Therapy: Intravenously on Day 1 Intensification Phase: Intravenously on day 1 of each cycle Continuation Phase: Intravenously on Day 1 of each cycle

DRUG

methotrexate

Induction: Intravenously on Day 2 MLL Intensification: Intravenously on Days 1, 8 Intensification: (when doxorubicin completed) Intravenously or into the muscle weekly Continuation: Intravenously or into the muscle weekly

DRUG

Leucovorin

Induction Phase: Intravenously or orally begins 36 hours after methotrexate MLL Intensification: Intravenously or orally begins 36 hours after methotrexate

DRUG

Asparaginase

Induction: Into the muscle on Day 4 MLL Intensification: Into the muscle on Days 16, 23

DRUG

cytarabine

Induction: Intrathecal on Days 0, 14, 28 MLL Intensification: Intravenously on Days 15, 16, 22, 23

DRUG

Methotrexate/Hydrocortisone

Induction: Intrathecal on Days 14, 28 MLL Intensification: Intrathecal on Days 2,9

Trial Locations (1)

02115

Dana-Farber Cancer Institute, Boston