Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Summary

This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Conditions

• Acute Lymphoblastic Leukemia
• Childhood B Acute Lymphoblastic Leukemia

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Some patients undergo cranial radiotherapy

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV or SC

DRUG

Dexamethasone

Given IV or PO

DRUG

Doxorubicin Hydrochloride

Given IV or IT

DRUG

Leucovorin Calcium

Given PO

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IM or IT

DRUG

Pegaspargase

Given IM

DRUG

Thioguanine

Given PO

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Kelly W Maloney · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-04-11

Primary Completion

2013-12-30

Completion

2021-03-31

Countries

• United States
• Australia
• Canada
• New Zealand
• Switzerland

Study Locations