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Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia

NCT00052299 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2012-08-27

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. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.

Conditions

Interventions

DRUG

cytarabine

DRUG

etoposide

DRUG

gemtuzumab ozogamicin

DRUG

idarubicin

DRUG

mitoxantrone hydrochloride

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Sergio Amadori, MD · Azienda Ospedallera Universitaria - Policlinico Tor Vergata, Roma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2008-01-31
Completion
2012-02-29

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal

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 NCT00052299 on ClinicalTrials.gov