CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 target
Drug / intervention
Gemtuzumab ozogamicindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00476541
NCT00476541Phase 3Completed
CompareCT.gov

NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

University of Aarhus·interventional·Posted May 22, 2007·Updated May 13, 2016

In Brief

A Phase 3 clinical trial evaluating Gemtuzumab ozogamicin for Acute Myeloid Leukemia. Completed, enrolled 250 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesDenmark
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 22, 2007
Enrollment StartJan 1, 2004
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 19.1 years ago

Interventions

Gemtuzumab ozogamicindrug

Two courses of Gemtuzumab vs. no further therapy