Treatment of Acute Lymphoblastic Leukemia in Children

Summary

The purpose of this study is to reduce the side-effects from anti-leukemia therapy. The therapy in this study is based upon treatment information learned from prior clinical research programs as well as from laboratory research.

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

Sponsors & Collaborators

• Boston Children's Hospital

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• McMaster University

  collaborator OTHER

• San Jorge Children's Hospital (Puerto Rico)

  collaborator UNKNOWN

• St. Justine's Hospital

  collaborator OTHER

• Maine Children's Cancer Program

  collaborator OTHER

• Ochsner Health System

  collaborator OTHER

• Tulane University School of Medicine

  collaborator OTHER

• Laval University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Dana-Farber Cancer Institute

  lead OTHER

Principal Investigators

• Lewis Silverman, MD · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-09-30

Primary Completion

2004-12-31

Completion

2011-05-31

Countries

• United States

Study Locations