Combination Chemotherapy Based on Risk of Relapse 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. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.

PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.

Conditions

• Leukemia

Interventions

DRUG

dexamethasone

10 mg/sqm/day from for 21 days

DRUG

asparaginase

native E-coli Asparaginase 5,000 IU/sqm x 8 doses

DRUG

Asparaginase

native E-Coli Asparaginase 10,000 IU/sqm x 4 doses

DRUG

cyclophosphamide

1,000 mg/sqm i.v. 2 doses in Induction phase 1000 mg/sqm i.v. 1 dose in Protocoll II 500 mg/sqm i.v. 1 dose in protocol III

DRUG

cytarabine

75 mg/sqm i.v.or s.c. 4 doses/week for 4 weeks in Induction phase 75 mg/sqm i.v.or s.c. 4 doses/week for 2 weeks in Protocol II and III

DRUG

daunorubicin

30 mg/sqm i.v. 4 doses in Induction phase

DRUG

doxorubicin

30 mg/sqm i.v. x 4 doses in Protocol II and III

DRUG

Etoposide

100 mg/sqm i.v. for 3 doses in HR block 3

DRUG

Ifosfamide

800 mg/sqm i.v.q12h x 5 in HR block 2

DRUG

mercaptopurine

60 mg/sqm p.o. c 28 days in Induction phase 60 mg/sqm p.o. x 56 days in Protocol M 50 mg/sqm daily in Maintenance phase

DRUG

Methotrexate

by age i.t. in Induction/Protocol M/Protocol II/Protocol III/HR Blocks and maintenance

DRUG

prednisone

60 mg/sqm daily p.o. for 28 days then tapered in Induction phase

DRUG

thioguanine

60 mg/sqm p.o. x 14 days in Protocol II and Protocol III

DRUG

Vincristine

1.5 mg/sqm i.v. x 4 doses in Induction phase and Protocol II 1.5 mg/sqm i.v. x 2 doses in Protocol III and HR block 1

DRUG

Vindesine

3 mg/sqm i.v. x 2 doses in HR block 2

Sponsors & Collaborators

• Associazione Italiana Ematologia Oncologia Pediatrica

  lead OTHER

Principal Investigators

• Giuseppe Masera, MD · Clinica Pediatrica Università di milano Bicocca

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-09-30

Primary Completion

2006-07-31

Completion

2006-07-31