Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Summary

This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell 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) and giving the drugs in different ways and different doses may kill more cancer cells..

Conditions

• B-cell Childhood Acute Lymphoblastic Leukemia
• L1 Childhood Acute Lymphoblastic Leukemia
• L2 Childhood Acute Lymphoblastic Leukemia
• Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia

Interventions

DRUG

vincristine sulfate

Given IV

DRUG

prednisone

Given PO

DRUG

doxorubicin hydrochloride

Given IV

DRUG

pegaspargase

Given IM

DRUG

cytarabine

Given IT or IV

DRUG

methotrexate

Given IT or IV

DRUG

dexamethasone

Given PO

DRUG

etoposide

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

leucovorin calcium

Given IV or PO

BIOLOGICAL

filgrastim

Given IV or SC

DRUG

asparaginase

Given IM

DRUG

mercaptopurine

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Glen Lew, MD · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

29 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-03-31

Primary Completion

2016-03-31

Countries

• United States
• Australia
• Canada
• Switzerland

Study Locations