Patients older than 60 years with newly diagnosed acute myeloid leukemia (AML)
Conditions
Interventions
Product Name: Sorafenib
Product Code: BAY-43-9006
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Sorafenib
Current Sponsor code: BAY-43-9006
Concentration unit: mg milligram(s)
Concentration
Sponsors
Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients older than 60 years with newly diagnosed AML (except APL) according to FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML) 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Central nervous system manifestations of AML -Uncontrolled active infection -Concurrent malignancies other than AML -Previous treatment of AML exept hydroxyurea and up to 2 days < or = 100 mg/m² cytarabine -Patients who are not eligible for standard chemotherapy as described in chapter 6.2 and 6.3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -to compare the median event free survival (EFS) of AML patients between the Sorafenib and the control group;Secondary Objective: -to compare the EFS of AML patients with Flt3 mutations between the Sorafenib and the control group -to compare EFS of AML patients in each of the four strata -to compare OS of AML patients between the Sorafenib and the control group -to compare the CR-rate of AML patients between the Sorafenib and the control group -to compare the molecular remissions of AML patients between the Sorafenib and the control group -to compare the toxicity between the Sorafenib and the control group -to compare the evidence of minimal residual disease of all AML patients between the Sorafenib and the control group after induction therapy and in the course of the first remission -to compare the development of biomarkers indicating the course of disease in leukemic blasts, bone marrow, peripheral blood cells, serum and plasma ;Primary end point(s): Event free Survival(EFS): measured from patient's day 1 of the study until treatment failure, relapse from CR or Morphologic leukemia-free state, or death from any cause, whichever occurs first. The time point at which the patient is resistant to therapy or survives induction without a CR or Morphologic leukemia-free state will be noted. For a patient with none of these events before the end of the study follow-up, observation of EFS will be censored at the date of his or her last follow-up examination. | — |
Countries
Germany
Outcome results
None listed