Clinical Trial Details

EORTC-06031

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Gemtuzumab ozogamicin (GO) monotherapy versus standard supportive care for previously untreated AML in elderly patients who are not eligible for intensive chemotherapy : a randomized phase II/III trial (AML-19) of the EORTC-LG and GIMEMA-ALWP.

Study documentation Publications

Trial Status All trial activities ended
Dates Date of activation: 28-Jun-2004
Date Step1 close: 02-May-2013
Data management at EORTC Yes
Design Phase 2-3
Randomized open label
Targeted Sample size EORTC Groups: 75 - All Groups: 267
Treatment Gemtuzumab
Study Staff
Type of cancer
Participating groups EORTC Leukemia Group
Gruppo Italiano Malattie Ematologiche dell'Adulto
Protocol summary http://clinicaltrials.gov/ct/show/NCT00091234
NCT number NCT00091234
EudraCT 2004-004356-39