drugset / Trial / NCT02182596

DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML

NCT02182596

Phase 1/2 Completed 20 enrolled Acute Leukemia French Association
Non-randomizedSingle-groupOpen-labelTreatment

Summary

For several years, the effective standard induction chemotherapy for AML has been limited to the association of anthracycline and aracytine. GO is the first effective targeted antibody used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated doses of GO used as a single agent for treatment of adult AML patients in first relapse. In the present study the possibility of combining fractionated doses of GO to escalated doses of a 3+7 regimen old is studied in relapsed AML patients \> 50 and \<70 years.

Timeline

Start
2006-06
Primary completion
2007-09
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemtuzumab Ozogamicin Monoclonal antibody 3 mg/m2 Intravenous