Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.

Conditions

• Leukemia

Interventions

BIOLOGICAL

sargramostim

DRUG

asparaginase

DRUG

cyclophosphamide

DRUG

cytarabine

DRUG

daunorubicin hydrochloride

DRUG

dexamethasone

DRUG

etoposide

DRUG

imatinib mesylate

DRUG

leucovorin calcium

DRUG

mercaptopurine

DRUG

methotrexate

DRUG

prednisone

DRUG

thioguanine

DRUG

vincristine sulfate

PROCEDURE

allogeneic bone marrow transplantation

PROCEDURE

autologous bone marrow transplantation

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Medical Research Council

  collaborator OTHER_GOV

• Eastern Cooperative Oncology Group

  lead NETWORK

Principal Investigators

• Jacob M. Rowe, MD · Rambam Health Care Campus

• Mark R. Litzow, MD · Mayo Clinic

• Antony H. Goldstone, FRCP · University College London Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1993-05-07

Primary Completion

2006-12-31

Countries

• United States

Study Locations