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NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

NCT00476541 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2016-05-13

No results posted yet for this study

Summary

The overall objective is to improve the cure rate of children with newly diagnosed acute myeloid leukemia (AML) who undergo risk-adapted therapy.

Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics and response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) will be evaluated.

Conditions

Interventions

DRUG

Gemtuzumab ozogamicin

Two courses of Gemtuzumab vs. no further therapy

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Henrik Hasle, MD · Department of Pediatrics, Aarhus University Hospital Skejby, Aarhus, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

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 NCT00476541 on ClinicalTrials.gov