Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
With
OSI Pharmaceuticals
The primary objective of this study is to determine the activity of OSI-461 given twice daily orally in previously untreated CLL patients. The secondary objective is to evaluate the safety profile of OSI-461 in this patient population.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood.
No previous therapy for CLL.
Expected remaining life span greater than or equal to six months.
18 years or older.
Willingness and ability to sign an informed consent.
You may not be if
Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
History of other malignancy which could affect the diagnosis or assessment of OSI-461.
Previous therapy for CLL.
Use of an investigational medication or device within one month of initiating study therapy.
Concurrent immunotherapy.
Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study).
Any condition or any medication which may interfere with the conduct of the study.
Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
