Risk-Adjusted Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

Summary

RATIONALE: 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) may kill more cancer cells. A donor stem cell transplant may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving combination chemotherapy before the transplant helps stop the growth of cancer cells and stop the patient's immune system from rejecting the donor's stem cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is studying different risk-adjusted combination chemotherapy regimens in treating young patients with acute lymphoblastic leukemia.

Conditions

• Leukemia

Interventions

DRUG

asparaginase

Given IV during reinduction

DRUG

cyclophosphamide

Given IV during reinduction

DRUG

cytarabine

Given IV during reinduction

DRUG

daunorubicin hydrochloride

Given IV during reinduction

DRUG

dexamethasone

Given IV or orally during reinduction

DRUG

doxorubicin hydrochloride

Given IV during reinduction

DRUG

etoposide

Given IV during reinduction

DRUG

ifosfamide

Given IV during reinduction

DRUG

leucovorin calcium

Given IV during reinduction

DRUG

mercaptopurine

Given orally during reinduction

DRUG

methotrexate

Given orally during reinduction

DRUG

prednisone

Given intrathecally during reinduction

DRUG

thioguanine

Given orally during reinduction

DRUG

vincristine sulfate

Given IV during reinduction

DRUG

vindesine

Given IV during reinduction

Sponsors & Collaborators

• University Hospital, Motol

  lead OTHER

Principal Investigators

• Jan Stary, MD · University Hospital, Motol

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-11-30

Primary Completion

2007-10-31

Countries

• Czechia

Study Locations