Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.

Conditions

• Leukemia
• Lymphoma

Interventions

DRUG

asparaginase

DRUG

cyclophosphamide

DRUG

cytarabine

DRUG

daunorubicin hydrochloride

DRUG

dexamethasone

DRUG

doxorubicin hydrochloride

DRUG

leucovorin calcium

DRUG

mercaptopurine

DRUG

methotrexate

DRUG

mitoxantrone hydrochloride

DRUG

prednisolone

DRUG

prednisone

DRUG

therapeutic hydrocortisone

DRUG

vincristine sulfate

PROCEDURE

allogeneic bone marrow transplantation

PROCEDURE

autologous bone marrow transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

• Acute Leukemia French Association

  collaborator OTHER

• European Organisation for Research and Treatment of Cancer - EORTC

  lead NETWORK

Principal Investigators

• Roel Willemze, MD, PhD · Leiden University Medical Center

• Denis Fiere, MD · Acute Leukemia French Association

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Min Age

15 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1995-08-31

Primary Completion

2004-03-31

Countries

• Belgium
• Croatia
• Czechia
• France
• Germany
• Italy
• Netherlands
• Portugal
• Slovakia
• Turkey (Türkiye)

Study Locations