Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

Summary

This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells.

Conditions

• Acute Lymphoblastic Leukemia
• Adult B Acute Lymphoblastic Leukemia
• Childhood B Acute Lymphoblastic Leukemia

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT and IV or SC

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT and PO

DRUG

Pegaspargase

Given IV

DRUG

Prednisone

Given IV or PO

RADIATION

Prophylactic Cranial Irradiation

Undergo radiation

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

• ZoAnn E Dreyer · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-23

Primary Completion

2014-06-30

Completion

2021-03-31

Countries

• United States
• Australia
• Canada

Study Locations