Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia

Conditions

• T-cell Childhood Acute Lymphoblastic Leukemia
• Untreated Childhood Acute Lymphoblastic Leukemia

Interventions

DRUG

prednisone

Given orally

DRUG

vincristine sulfate

Given IV

DRUG

daunorubicin hydrochloride

Given IV

DRUG

asparaginase

Given IM

DRUG

methotrexate

Given IT and orally

DRUG

cyclophosphamide

Given IV

DRUG

cytarabine

Given IV or SC

DRUG

mercaptopurine

Given orally

DRUG

leucovorin calcium

Given IV or orally

DRUG

dexamethasone

Given orally

DRUG

doxorubicin hydrochloride

Given IV

DRUG

thioguanine

Given orally

RADIATION

radiation therapy

Undergo cranial irradiation

DRUG

nelarabine

Given IV

DRUG

pegaspargase

Given IM

RADIATION

radiation therapy

Undergo craniocervical radiotherapy

OTHER

pharmacological study

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Kimberly Dunsmore · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-04-30

Primary Completion

2007-07-31

Countries

• United States

Study Locations