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Description:

ODM derived from http://clinicaltrials.gov/show/NCT00373373

Link:

http://clinicaltrials.gov/show/NCT00373373

Versions (3)

12/11/13 12/11/13 - Martin Dugas
4/14/14 4/14/14 - Julian Varghese
9/20/21 9/20/21 -

Uploaded on:

September 20, 2021

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License :

Creative Commons BY 4.0

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Eligibility NCT00373373 Acute Myeloid Leukemia

English 2

German English

Details

Eligibility

1 forms

StudyEvent: Eligibility
1. Eligibility

Inclusion Criteria

age >= 61 Years

Yes

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)

Yes

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

Yes

Age >= 61 years

Yes

Informed consent, personally signed and dated to participate in the study

Yes

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

Yes

Exclusion Criteria

Central nervous system manifestation of AML

Yes

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)

Yes

Chronically impaired renal function (creatinin clearance < 30 ml/min)

Yes

Chronic pulmonary disease with relevant hypoxia

Yes

Inadequate liver function (ALT and AST >= 2.5 x ULN)

Yes

Total bilirubin >= 1.5 x ULN

Yes

Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg

Yes

Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol

Yes

Uncontrolled active infection

Yes

Concurrent malignancies other than AML

Yes

Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m2/d cytarabine

Yes

Known HIV and/or hepatitis C infection

Yes

Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders

Yes

Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry

Yes

Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy

Yes

History of organ allograft

Yes

Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg

Yes

Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose

Yes

Serious, non-healing wound, ulcer or bone fracture

Yes

Allergy to study medication or excipients in study medication

Yes

Investigational drug therapy outside of this trial during or within 4 weeks of study entry

Yes

Patients who are not eligible for standard chemotherapy

Yes

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