Sorafenib added to standard primary therapy in patients with newly diagnosed AML = 60 years of age MedDRA version: 17.0 Level: LLT Classification code 10001941 Term: AML System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Nexavar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sorafenib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: -800
Pharmaceutical form
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML) • Bone marrow aspirate or biopsy must contain = 20% blasts of all nucleated cells or differential blood count must contain = 20% blasts. In AML FAB M6 = 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who are not eligible for standard chemotherapy • Central nervous system manifestation of AML • Cardiac Disease: Heart failure NYHA III° or IV°; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) • Chronically impaired renal function (creatinine clearance Grade 2 NCI-CTC version 3.0 • Concurrent malignancies other than AML • History of organ allograft • Allergy to study medication or excipients in study medication • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 3 months after completion of trial • Previous treatment of AML except hydoxyurea for up to 5 days • Concomitant or previous treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg • Investigational drug therapy outside of this trial during or within 4 weeks of study entry • Patients unable to swallow oral medications • Substance abuse, medical, psychological or social conditions that may interfere with the patient´s participation in the study or evaluation of these study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the median Event Free Survival (EFS) of AML patients in the age of =18 and = 60 years between the Sorafenib and the control group;Secondary Objective: • to compare the median Event Free Survival (EFS) of AML patients with Flt3-ITD mutations between the Sorafenib and the control group • to compare the median EFS of the patients in each of six strata (see protocol) • to compare the median Overall Survival (OS) of AML patients with Flt3-ITD mutations • to compare the median Overall Survival (OS) of all AML patients • to compare the CR rate • to compare the rate of molecular remissions • to compare the toxicity • to compare the evidence of minimal residual disease of all AML patients after induction therapy and in the course of the first remission • to compare early treatment efficacy (day 16 bone marrow assessment) • to compare the development of biomarkers indicating the course of disease, including genetic, epigenetic, transcriptional and protein markers in leukemic blasts, bone marrow, peripheral blood cells, serum and plasma;Primary end point(s): the median Event Free Survival (EFS) | — |
Countries
Germany
Contacts
Public ContactMK1, Klinische Studien
Universitätsklinikum Dresden
Outcome results
None listed