Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

University Hospital Muenster

Status and phase

Completed

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Placebo

Drug: Sorafenib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00373373

Sorafenib in AML

EudraCT Number: 2005-005966-35

KKS/INNERE_A/AML2006

Details and patient eligibility

About

The primary purpose of the study is to determine, whether the addition of Sorafenib to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).

Enrollment

200 estimated patients

Sex

All

Ages

61+ years old

Volunteers

No Healthy Volunteers

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, with the exception of AML FAB M6, where >= 30% of non-erythroid cells must be leukemic blasts
Age >= 61 years
Informed consent, personally signed and dated to participate in the study
Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the Sorafenib treatment and for at least 3 months after the last administration of Sorafenib

Exclusion criteria

Central nervous system manifestation of AML
Cardiac Disease: Heart failure NYHA III° or IV°; active 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 (creatinin clearance < 30 ml/min)
Chronic pulmonary disease with relevant hypoxia
Inadequate liver function (ALT and AST >= 2.5 x ULN)
Total bilirubin >= 1.5 x ULN
Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
Uncontrolled active infection
Concurrent malignancies other than AML
Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m²/d cytarabine
Known HIV and/or hepatitis C infection
Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders
Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
History of organ allograft
Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
Serious, non-healing wound, ulcer or bone fracture
Allergy to study medication or excipients in study medication
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Patients who are not eligible for standard chemotherapy