primary refractory patients with acute myeloid leukemia
Conditions
Interventions
Trade Name: Mylotarg
Product Name: Gemtuzumab Ozogamicin
Product Code: GO
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Universitätsklinikum Ulm / University Clinical Center Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) acute myeloid leukemia defined according the WHO classification not responding to first induction therapy 2.) age 18-60 years 3.) written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.) acute promyelocytic leukemia 2.) uncontrolled infection 3.) transfusion-refractory thrombocytopenia 4.) pregnancy, breast-feeding, insufficient contraception 5.) participation in other controlled clinical trials 6.) organ insufficiency: kidneys, liver, lungs, heart 7.) severe neurological or psychiatrical condition interfering with informed consent 8.) No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course 9.) performance status > grad 2 according the WHO classification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: improvement of the complete remission rate after salvage therapy within the present protocol of patients with acute myeloid leukemia who failed to achieve a complete or partial remission after first induction therapy;Secondary Objective: 1.) evaluation of the safety of the salvage therapy within the present protocol consisting of a combination chemotherapy 2.) evaluation of the influence of the salvage therapy within the present protocol consisting of a combination chemotherapy on the incidence of veno occlusive disease after subsequent allogeneic transplantation 3.) evaluation of the influence of the salvage therapy within the present protocol consisting of a combination chemotherapy on the overall survival compared to historical controls of our previous multicenter studies;Primary end point(s): rate of complete remissions after salvage therapy within the present protocol | — |
Countries
Austria
Outcome results
None listed