A Study in Adults With Untreated Acute Lymphoblastic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2002

Primary Completion Date

November 30, 2008

Study Completion Date

May 31, 2011

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

prednisone

Induction Phase: Given orally on days 1-28

DRUG

doxorubicin

Induction Phase: Given intravenously on day 1 and day 2 CNS Therapy: Given intravenously on day 1 Intensification: Given day 1 of each cycle

DRUG

vincristine

"Induction: Given intravenously on days 1, 8, 15, and 22. If complete remission not achieved, will be given on days 29, 36 and 43.~CNS Therapy: Given intravenously on day 1. Intensification: Given intravenously on day 1 of each cycle. Continuation: Given intravenously on day 1 of each cycle"

DRUG

methotrexate

Induction: Given intravenously on day 3. CNS Therapy: Given intrathecally 4 times over two weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intravenously weekly and intrathecally every 18 weeks

DRUG

asparaginase

Induction: Given into the muscle on day 5

DRUG

dexamethasone

Intensification: Given orally on days 1-5 of each cycle

RADIATION

cranial radiation

Given in 10 daily treatments during CNS therapy phase

DRUG

leucovorin

Induction: Given intravenously or orally 36 hours after methotrexate

DRUG

cytarabine

Induction: Given intrathecally days 1, 15, 29 CNS Therapy: Given intrathecally 4 times over 2 weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intrathecally every 18 weeks

DRUG

hydrocortisone

Induction: Given intrathecally on days 15 and 29. Intensification: Given intrathecally every 18 weeks. Continuation: Given intrathecally every 18 weeks.

DRUG

6-mercaptopurine (6-MP)

CNS Therapy: Taken orally on days 1-14. Intensification: Taken orally on days 1-14. Continuation: Taken orally on days 1-14.

DRUG

e. coli L-asparaginase

Intensification: Given in to the muscle weekly.

Trial Locations (12)

02115

Dana-Farber Cancer Institute, Boston

Massachusetts General Hospital, Boston

Unknown

University Of Columbia Medical Center, New York

Manitoba Blood & Marrow Transplant Program CancerCare Manitoba, Winnipeg

McMaster University Medical Center, Hamilton

Queen's University, Kingston

London Health Sciences Centre, London

Sunnybrook Health Sciences Centre, Toronto

Hospital Maisonneuve-Rosemont, Montreal

Royal Victoria Hospital, Montreal

Saskatoon Cancer Centre, Saskatoon

Queen Elizabeth II, Halifax

All Listed Sponsors
collaborator

Brigham and Women's Hospital

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

Queen Elizabeth II Health Sciences Centre

OTHER

lead

Dana-Farber Cancer Institute

OTHER

NCT00136435 - A Study in Adults With Untreated Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter