Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia.

Conditions

• Leukemia

Interventions

DRUG

asparaginase

DRUG

cyclophosphamide

DRUG

cyclosporine

DRUG

cytarabine

DRUG

daunorubicin hydrochloride

DRUG

dexamethasone

DRUG

doxorubicin hydrochloride

DRUG

mercaptopurine

DRUG

methotrexate

DRUG

methylprednisolone

DRUG

pegaspargase

DRUG

thioguanine

DRUG

vincristine sulfate

PROCEDURE

allogeneic bone marrow transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Paul S. Gaynon, MD · Children's Hospital Los Angeles

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-11-30

Primary Completion

2005-01-31

Completion

2006-04-30

Countries

• United States
• Australia
• Canada

Study Locations