A Study in Adults With Untreated Acute Lymphoblastic Leukemia

Summary

The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.

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.

Sponsors & Collaborators

• Brigham and Women's Hospital

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Queen Elizabeth II Health Sciences Centre

  collaborator OTHER

• Dana-Farber Cancer Institute

  lead OTHER

Principal Investigators

• Daniel J. DeAngelo, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-06-30

Primary Completion

2008-11-30

Completion

2011-05-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations