MedTrace Logo

Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia

NCT00002719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2012-07-02

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in the bone marrow or peripheral blood and may help a person's immune system recover after chemotherapy and radiation therapy. Combining more than one drug and giving drugs in different ways may kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without G-CSF in treating older patients with acute myeloid leukemia.

Conditions

Interventions

BIOLOGICAL

filgrastim

DRUG

amsacrine

DRUG

carmustine

DRUG

cytarabine

DRUG

etoposide

DRUG

idarubicin

DRUG

mitoxantrone hydrochloride

PROCEDURE

peripheral blood stem cell transplantation

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

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

  • Franco Mandelli, MD · Azienda Policlinico Umberto Primo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
61 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-12-31
Primary Completion
2001-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002719 on ClinicalTrials.gov