Chronic Lymphocytic Leukemia
Conditions
Keywords
chronic leukemia, leukemia, CLL
Brief summary
The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.
Detailed description
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.
Interventions
DRUGOSI-461
Sponsors
OSI Pharmaceuticals
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Evidence of CNS involvement. * Pregnant or nursing women.
Countries
United States
Outcome results
None listed